Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 LaserNCT05272787
Clinical Trial to Evaluate Safety and Efficacy of a Facial and Lip Moisturizer in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser
A study testing TH Facial Moisturizer, TH Lip Moisturizer and Sunscreen in people with Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.
Trial summary
This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser
- What is being tested?
- TH Facial Moisturizer, TH Lip Moisturizer and Sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2022to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or Female
- 18 to 65 years old
- Fitzpatrick Skin Type I to III
- Generally in good health based on medical history reported by the subject.
- Subjects presenting dry/dried up lips, proven by dermatologist.
- Subjects who have some cutaneous condition whose performance of the Fractional CO2 Laser procedure is recommended by the dermatologist, for example facial spots and/or acne scars and/or facial wrinkles.
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- Able to read, write, speak, and understand Portuguese.
- Individual has signed the ICD.
- Agree to the performance of the Fractional CO2 Laser procedure by the dermatologist.
- Agree to use two facial products, each on one half face, and one lip product.
- Agree to use the facial sunscreen provided during the conditioning period and during sun exposure.
- Agree to replace their usual facial wash with the facial wash provided for facial cleansing during the conditioning period and during the study.
- For male participants: agree to shave the day before visits 2, 4 and 5.
- Intends to complete the study and is willing and able to follow all study instructions.
Who cannot join
- Has known allergies or adverse reactions to common topical skincare products including facial moisturizer, sunscreen and liquid soap.
- Have known allergies or adverse reactions to the Pliaglis anesthetic cream that will be used for the dermatological facial procedure.
- Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer).
- Presents with primary/secondary lesions (scar - except from acne, ulcers, vesicles) or tattoos on test sites.
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
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- Immunosuppressive or steroidal drugs within 2 months before Visit 1*
- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1*
- Antihistamines within 2 weeks before Visit 1*
- If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the Study Physician should be consulted to consider the impact of the specific medication on subject safety and/or the study results, as described in section "Concurrent/Concomitant Medication".
- Is self-reported to be pregnant or planning to become pregnant during the study.
- Subjects with a history of keloid formation.
- Subject with a history of Herpes.
- Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
- Test positive for COVID-19 at visit 2 according to the rapid antigen test (COVID-19 Ag Immuno-Rapid Kit).
- Is simultaneously participating in any other clinical study.
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
- History of a confirmed COVID-19 infection in the last 30 days.
- Contact with COVID-19-infected person within 14 days prior to all on-site visits.
- Any international travel within 14 days prior to all on-site visits including members in the same household.
- Subjects with self-reported symptoms within the past 2 weeks:
- Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness.
- Temperature ≥ 38.0°C /100.4°F, measured.
- Use of fever reducers within the past 2 days of each onsite visit.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmetica Ltda
Campinas, São Paulo, 13084-791
About this study
Official title: A Single-Center, Open-Label, Randomized Safety-in-Use Clinical Study to Assess the Topical Tolerability and Efficacy of a Facial Moisturizer and Lip Moisturizer During and After 21±2 Days of Use in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser
This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2 Laser under the supervision of a dermatologist. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and perceived efficacy through subjective perception questionnaires will be evaluated. Subjects will receive the product to use it at home for 21 +/- 2 days.
- Being tested
- TH Facial Moisturizer, TH Lip Moisturizer, Facial Moisturizer B (Control), Sunscreen, Facial wash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH Facial MoisturizerOther
Also called The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.
All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
TH Lip MoisturizerOther
Also called The lip lotion product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.
All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
Facial Moisturizer B (Control)Other
Also called The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.
All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.
SunscreenOther
Also called It will be used all over the face whenever there is the intention of sun exposure.
Auxiliary product
Facial washOther
Also called It will be used to wash the face at least once daily.
Auxiliary product.
| Study group | Role | What they receive |
|---|---|---|
| Left face TH Facial Moisturizer | Experimental | All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the left side of the face, then the Facial Moisturizer B (Control) will be applied on the right side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study. Receives: Other: TH Facial Moisturizer; Other: TH Lip Moisturizer; Other: Facial Moisturizer B (Control); Other: Sunscreen; Other: Facial wash |
| Right face TH Facial Moisturizer | Experimental | All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the right side of the face, then the Facial Moisturizer B (Control) will be applied on the left side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study. Receives: Other: TH Facial Moisturizer; Other: TH Lip Moisturizer; Other: Facial Moisturizer B (Control); Other: Sunscreen; Other: Facial wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of scores of erythema to 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of desquamation to 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of blistering to 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of edema to 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Measured: 21 ± 2 days.
Percentage of participants with Adverse Events through 21 ± 2 days.
The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.
Measured: 21 ± 2 days.
Secondary outcomes (117)
Change from baseline of the scores of erythema to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of erythema to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of erythema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: 21 ± 2 days.
Change from baseline of the scores of erythema to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of erythema to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of erythema scores at5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of erythema to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of erythema to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of erythema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of erythema to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of erythema to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of erythema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of erythema to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of erythema to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of erythema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Change from baseline of the scores of edema to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of edema to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of edema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Change from baseline of the scores of edema to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of edema to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of edema scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of edema to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of edema to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of edema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of edema to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of edema to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of edema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of edema to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of edema to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of edema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Change from baseline of the scores of dryness to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of dryness to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of dryness scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Change from baseline of the scores of dryness to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of dryness to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of dryness scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of dryness to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of dryness to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of dryness scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of dryness to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of dryness to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of dryness scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of dryness to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of dryness to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of dryness scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified dryness according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Change from baseline of the scores of desquamation to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of desquamation to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of desquamation scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Change from baseline of the scores of desquamation to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of desquamation to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of desquamation scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of desquamation to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of desquamation to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of desquamation scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of desquamation to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of desquamation to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of desquamation scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of desquamation to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of desquamation to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of desquamation scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Change from baseline of the scores of stinging to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of stinging to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of stinging scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Change from baseline of the scores of stinging to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of stinging to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of stinging scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of stinging to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of stinging to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of stinging scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of stinging to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of stinging to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of stinging scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of stinging to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of stinging to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of stinging scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified stingings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Change from baseline of the scores of itching to 21 ± 2 days for TH facial moisturizer.
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 21 ± 2 days.
Change from baseline of the scores of itching to 21 ± 2 days for Facial Moisturizer B (Control).
At baseline and at 21 ± 2 days, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 21 ± 2 days.
Comparison of itching scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 21 ± 2 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Change from baseline of the scores of itching to 5 ± 1 day for TH facial moisturizer.
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 5 ± 1 day.
Change from baseline of the scores of itching to 5 ± 1 day for Facial Moisturizer B (Control).
At baseline and at 5 ± 1 day, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 5 ± 1 day.
Comparison of itching scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
At 5 ± 1 day, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 5 ± 1 day scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 5 ± 1 day.
Change from baseline of the scores of itching to 24 hours for TH facial moisturizer.
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 24 hours.
Change from baseline of the scores of itching to 24 hours for Facial Moisturizer B (Control).
At baseline and at 24 hours, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 24 hours.
Comparison of itching scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 24 hours scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Change from baseline of the scores of itching to 1 hour for TH facial moisturizer.
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 1 hour.
Change from baseline of the scores of itching to 1 hour for Facial Moisturizer B (Control).
At baseline and at 1 hour, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 1 hour.
Comparison of itching scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 1-hour scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Change from baseline of the scores of itching to 30 minutes for TH facial moisturizer.
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the TH Facial moisturizer.
Measured: 30 minutes.
Change from baseline of the scores of itching to 30 minutes for Facial Moisturizer B (Control).
At baseline and at 30 minutes, the study physician will evaluate the corresponding half face and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on the corresponding half face. The change from baseline will be evaluated to assess the clinical efficacy of the Facial Moisturizer B (Control).
Measured: 30 minutes.
Comparison of itching scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
At 30 minutes, the study physician will evaluate both half faces and score the identified itching according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense).
This scale will be used to classify the clinical evaluation on each half face. The 30 minutes scores of each half face will be compared with each other to compare the clinical efficacy of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 30 minutes.
Self-Perceived Efficacy Questionnaire at 30 minutes
Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale).
This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.
Measured: 30 minutes
Self-Perceived Efficacy Questionnaire at 24 hours
Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale).
This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.
Measured: 24 hours
Self-Perceived Efficacy Questionnaire at 5 ± 1 day
Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturezer produts. Participants will answer each question using a qualitative scale (agreement scale).
This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.
Measured: 5 ± 1 day
Self-Perceived Efficacy Questionnaire at 21 ± 2 days
Perceived efficacy related to the product usage will be subjectively evaluated by the participants through a questionnaire with questions related to use of the TH facial moisturizer and TH lip moisturizer products. Participants will answer each question using a qualitative scale (agreement scale).
This questionnaire will be used to evaluate the efficacy of TH Facial Moisturizing and TH Lip Moisturizer regarding skin regeneration after dermatological facial procedure with CO2 fractional laser in adult participants. The responses for each question will be provided as percentages.
Measured: 21 ± 2 days
Visual skin condition of the whole face at baseline captured photographically
Face images will be captured using a recognized device (Visia CR) at baseline to visualize the skin condition of these areas after the dermatological facial procedure with CO2 fractional laser and before the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face.
No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.
Measured: baseline
Visual skin condition of the whole face at 1 hour captured photographically
Face images will be captured using a recognized device (Visia CR) at 1 hour to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) supervised application on each determined half face.
No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.
Measured: 1 hour
Visual skin condition of the whole face at 24 hours captured photographically
Face images will be captured using a recognized device (Visia CR) at 24 hours to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face.
No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.
Measured: 24 hours
Visual skin condition of the whole face at 5 ± 1 day captured photographically
Face images will be captured using a recognized device (Visia CR) at 5 ± 1 day to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face.
No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.
Measured: 5 ± 1 day
Visual skin condition of the whole face at 21 ± 2 days captured photographically
Face images will be captured using a recognized device (Visia CR) at 21 ± 2 days to visualize the skin condition of these areas after the TH Facial moisturizer and Facial Moisturizer B (Control) usage on each determined half face.
No analysis is planned. These images will be used as a qualitative complement to the other results for TH Facial moisturizer.
Measured: 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level for TH facial moisturizer.
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.
Measured: 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level for Facial Moisturizer B (Control).
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.
Measured: 21 ± 2 days
Comparison of skin hydration level at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage. The 21 ± 2 days measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Mean change from baseline to 24 hours in skin hydration level for TH facial moisturizer.
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.
Measured: 24 hours
Mean change from baseline to 24 hours in skin hydration level for Facial Moisturizer B (Control).
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.
Measured: 24 hours
Comparison of skin hydration level at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. The 24 hours measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Mean change from baseline to 1 hour in skin hydration level for TH facial moisturizer.
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the TH facial moisturizer on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application.
Measured: 1 hour
Mean change from baseline to 1 hour in skin hydration level for Facial Moisturizer B (Control).
Skin hydration level of the determined half face will be measured with corneometer, a recognized device that determine the water content of stratum corneum. This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser 1 hour of supervised application.
Measured: 1 hour
Comparison of skin hydration level at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, skin hydration level of both half faces will be measured with corneometer, a recognized device that determine the water content of stratum corneum.
This measure will be used to determine the effect of both products on skin hydration of the study population who underwent the dermatological facial procedure with CO2 fractional laser 1 hour of supervised application. The 1-hour measures of each half face will be compared with each other to compare the skin hydration of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.
Measured: 21 ± 2 days
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage.
Measured: 21 ± 2 days
Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
At 21 ± 2 days, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 21 ± 2 days of usage. The 21 ± 2 days measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 21 ± 2 days.
Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
Measured: 24 hours
Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage.
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
Measured: 24 hours
Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
At 24 hours, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 24 hours of usage. The 24 hours measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 24 hours.
Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
This measure will be used to determine the effect of the TH facial moisturizer on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application.
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
Measured: 1 hour
Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
This measure will be used to determine the effect of the Facial Moisturizer B (Control) on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application.
Skin barrier integrity of the determined half face will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
Measured: 1 hour
Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
At 1 hour, the transepidermal water loss of both half faces will be measured with Tewameter, a recognized device that determine the transepidermal water loss. Lower levels of TEWL may be related to a more integrate skin barrier.
This measure will be used to determine the effect of both products on skin barrier integrity of the study population who underwent the dermatological facial procedure with CO2 fractional laser after 1 hour of supervised application. The 1-hour measures of each half face will be compared with each other to compare the skin barrier integrity of one product with the other (TH facial moisturizer versus Facial Moisturizer B (Control)).
Measured: At 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start10 Mar 2022
- Primary completion13 Apr 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 LaserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All participants will receive the same study regimen consisting of 5 products: a facial moisturizer, a facial moisturizer (control), a lip moisturizer, a sunscreen and a facial wash.The facial moisturizers will be applied on the half face. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariane Martins Mosca, Bsc., Principal investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272787
- Sponsor's protocol ID
- CCSSKA004711
- Status last verified
- Jun 2023
- First submitted
- 25 Feb 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Publications
Petrov A. Efficiency of Carbon Dioxide Fractional Laser in Skin Resurfacing. Open Access Maced J Med Sci. 2016 Jun 15;4(2):271-6. doi: 10.3889/oamjms.2016.062. Epub 2016 May 24.
PubMed 27335599Krupa Shankar D, Chakravarthi M, Shilpakar R. Carbon dioxide laser guidelines. J Cutan Aesthet Surg. 2009 Jul;2(2):72-80. doi: 10.4103/0974-2077.58519.
PubMed 20808594Zahr AS, Kononov T, Sensing W, Biron JA, Gold MH. An open-label, single-site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full-face radiofrequency microneedling treatment. J Cosmet Dermatol. 2019 Feb;18(1):94-106. doi: 10.1111/jocd.12817. Epub 2018 Nov 19.
PubMed 30456804ASSOCIAÇÃO MÉDICA MUNDIAL. Declaração de Helsinque. Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.
BRASIL. Ministério da Saúde. RDC nº 466, de 12 de dezembro 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos.
Canfield Scientific. Visia CR: Facial Imaging System for Clinical Research. The Measuring Principle.
Courage + Khazaka electronic GmbH. Corneometer® CM 825. The Measuring Principle.
Courage + Khazaka electronic GmbH. Tewameter® TM 300. The Measuring Principle.
Courage + Khazaka electronic GmbH. Tewameter® TM Nano. The Measuring Principle.
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.
PubMed 11590294OPAS. Organização Pan-Americana de Saúde. Boas Práticas Clínicas: Documento das Américas. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica, 2005.
WAMA Diagnóstica. Guia para o teste rápido de antígeno: Kit Imuno-Rápido COVID-19 Ag. 2021.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized Safety-in-Use Clinical Study to Assess the Topical Tolerability and Efficacy of a Facial Moisturizer and Lip Moisturizer During and After 21±2 Days of Use in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser
- ClinicalTrials.gov ID
- NCT05272787
- Acronym / sponsor ID
- CCSSKA004711
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2 Laser under the supervision of a dermatologist. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and perceived efficacy through subjective perception questionnaires will be evaluated. Subjects will receive the product to use it at home for 21 +/- 2 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive the same study regimen consisting of 5 products: a facial moisturizer, a facial moisturizer (control), a lip moisturizer, a sunscreen and a facial wash.The facial moisturizers will be applied on the half face. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge.
| Arm | Type | Receives |
|---|---|---|
| Left face TH Facial Moisturizer | Experimental | Other: TH Facial Moisturizer, Other: TH Lip Moisturizer, Other: Facial Moisturizer B (Control), Other: Sunscreen, Other: Facial washAll subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the left side of the face, then the Facial Moisturizer B (Control) will be applied on the right side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study. |
| Right face TH Facial Moisturizer | Experimental | Other: TH Facial Moisturizer, Other: TH Lip Moisturizer, Other: Facial Moisturizer B (Control), Other: Sunscreen, Other: Facial washAll subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the right side of the face, then the Facial Moisturizer B (Control) will be applied on the left side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and/or Female
- 18 to 65 years old
- Fitzpatrick Skin Type I to III
- Generally in good health based on medical history reported by the subject.
- Subjects presenting dry/dried up lips, proven by dermatologist.
Key exclusion criteria (24 listed)
- Has known allergies or adverse reactions to common topical skincare products including facial moisturizer, sunscreen and liquid soap.
- Have known allergies or adverse reactions to the Pliaglis anesthetic cream that will be used for the dermatological facial procedure.
- Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer).
- Presents with primary/secondary lesions (scar - except from acne, ulcers, vesicles) or tattoos on test sites.
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH Facial MoisturizerAlso: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. | Other | Left face TH Facial Moisturizer, Right face TH Facial Moisturizer |
| TH Lip MoisturizerAlso: The lip lotion product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. | Other | Left face TH Facial Moisturizer, Right face TH Facial Moisturizer |
| Facial Moisturizer B (Control)Also: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. | Other | Left face TH Facial Moisturizer, Right face TH Facial Moisturizer |
| SunscreenAlso: It will be used all over the face whenever there is the intention of sun exposure.Auxiliary product | Other | Left face TH Facial Moisturizer, Right face TH Facial Moisturizer |
| Facial washAlso: It will be used to wash the face at least once daily.Auxiliary product. | Other | Left face TH Facial Moisturizer, Right face TH Facial Moisturizer |
Primary outcome
Change from baseline of scores of erythema to 21 ± 2 days.
Time frame: 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Change from baseline of the scores of desquamation to 21 ± 2 days.
Time frame: 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified desquamations according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Change from baseline of the scores of blistering to 21 ± 2 days.
Time frame: 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Change from baseline of the scores of edema to 21 ± 2 days.
Time frame: 21 ± 2 days.
At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.
Percentage of participants with Adverse Events through 21 ± 2 days.
Time frame: 21 ± 2 days.
The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.
117 secondary outcomes
Change from baseline of the scores of erythema to 21 ± 2 days for TH facial moisturizer.
Time frame: 21 ± 2 days.
Change from baseline of the scores of erythema to 21 ± 2 days for Facial Moisturizer B (Control).
Time frame: 21 ± 2 days.
Comparison of erythema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: 21 ± 2 days.
Change from baseline of the scores of erythema to 5 ± 1 day for TH facial moisturizer.
Time frame: 5 ± 1 day.
Change from baseline of the scores of erythema to 5 ± 1 day for Facial Moisturizer B (Control).
Time frame: 5 ± 1 day.
Comparison of erythema scores at5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 5 ± 1 day.
Change from baseline of the scores of erythema to 24 hours for TH facial moisturizer.
Time frame: 24 hours.
Change from baseline of the scores of erythema to 24 hours for Facial Moisturizer B (Control).
Time frame: 24 hours.
Comparison of erythema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 24 hours.
Change from baseline of the scores of erythema to 1 hour for TH facial moisturizer.
Time frame: 1 hour.
Change from baseline of the scores of erythema to 1 hour for Facial Moisturizer B (Control).
Time frame: 1 hour.
Comparison of erythema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 1 hour.
Change from baseline of the scores of erythema to 30 minutes for TH facial moisturizer.
Time frame: 30 minutes.
Change from baseline of the scores of erythema to 30 minutes for Facial Moisturizer B (Control).
Time frame: 30 minutes.
Comparison of erythema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 30 minutes.
Change from baseline of the scores of edema to 21 ± 2 days for TH facial moisturizer.
Time frame: 21 ± 2 days.
Change from baseline of the scores of edema to 21 ± 2 days for Facial Moisturizer B (Control).
Time frame: 21 ± 2 days.
Comparison of edema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 21 ± 2 days.
Change from baseline of the scores of edema to 5 ± 1 day for TH facial moisturizer.
Time frame: 5 ± 1 day.
Change from baseline of the scores of edema to 5 ± 1 day for Facial Moisturizer B (Control).
Time frame: 5 ± 1 day.
Comparison of edema scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 5 ± 1 day.
Change from baseline of the scores of edema to 24 hours for TH facial moisturizer.
Time frame: 24 hours.
Change from baseline of the scores of edema to 24 hours for Facial Moisturizer B (Control).
Time frame: 24 hours.
Comparison of edema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 24 hours.
Change from baseline of the scores of edema to 1 hour for TH facial moisturizer.
Time frame: 1 hour.
Change from baseline of the scores of edema to 1 hour for Facial Moisturizer B (Control).
Time frame: 1 hour.
Comparison of edema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 1 hour.
Change from baseline of the scores of edema to 30 minutes for TH facial moisturizer.
Time frame: 30 minutes.
Change from baseline of the scores of edema to 30 minutes for Facial Moisturizer B (Control).
Time frame: 30 minutes.
Comparison of edema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 30 minutes.
Change from baseline of the scores of dryness to 21 ± 2 days for TH facial moisturizer.
Time frame: 21 ± 2 days.
Change from baseline of the scores of dryness to 21 ± 2 days for Facial Moisturizer B (Control).
Time frame: 21 ± 2 days.
Comparison of dryness scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 21 ± 2 days.
Change from baseline of the scores of dryness to 5 ± 1 day for TH facial moisturizer.
Time frame: 5 ± 1 day.
Change from baseline of the scores of dryness to 5 ± 1 day for Facial Moisturizer B (Control).
Time frame: 5 ± 1 day.
Comparison of dryness scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 5 ± 1 day.
Change from baseline of the scores of dryness to 24 hours for TH facial moisturizer.
Time frame: 24 hours.
Change from baseline of the scores of dryness to 24 hours for Facial Moisturizer B (Control).
Time frame: 24 hours.
Comparison of dryness scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
Time frame: At 24 hours.
Change from baseline of the scores of dryness to 1 hour for TH facial moisturizer.
Time frame: 1 hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 27335599Petrov A. Efficiency of Carbon Dioxide Fractional Laser in Skin Resurfacing. Open Access Maced J Med Sci. 2016 Jun 15;4(2):271-6. doi: 10.3889/oamjms.2016.062. Epub 2016 May 24.
- Background: PubMed 20808594Krupa Shankar D, Chakravarthi M, Shilpakar R. Carbon dioxide laser guidelines. J Cutan Aesthet Surg. 2009 Jul;2(2):72-80. doi: 10.4103/0974-2077.58519.
- Background: PubMed 30456804Zahr AS, Kononov T, Sensing W, Biron JA, Gold MH. An open-label, single-site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full-face radiofrequency microneedling treatment. J Cosmet Dermatol. 2019 Feb;18(1):94-106. doi: 10.1111/jocd.12817. Epub 2018 Nov 19.
- BackgroundASSOCIAÇÃO MÉDICA MUNDIAL. Declaração de Helsinque. Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.
- BackgroundBRASIL. Ministério da Saúde. RDC nº 466, de 12 de dezembro 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos.
- BackgroundCanfield Scientific. Visia CR: Facial Imaging System for Clinical Research. The Measuring Principle.
- BackgroundCourage + Khazaka electronic GmbH. Corneometer® CM 825. The Measuring Principle.
- BackgroundCourage + Khazaka electronic GmbH. Tewameter® TM 300. The Measuring Principle.
- BackgroundCourage + Khazaka electronic GmbH. Tewameter® TM Nano. The Measuring Principle.
- Background: PubMed 11590294International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.
- BackgroundOPAS. Organização Pan-Americana de Saúde. Boas Práticas Clínicas: Documento das Américas. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica, 2005.
- BackgroundWAMA Diagnóstica. Guia para o teste rápido de antígeno: Kit Imuno-Rápido COVID-19 Ag. 2021.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariane Martins Mosca, Bsc. principal investigator
Allergisa Pesquisa Dermato-Cosmetica LTDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TH Facial Moisturizer, TH Lip Moisturizer and Sunscreen in people with Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of scores of erythema to 21 ± 2 days. (time frame: 21 ± 2 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272787, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.