Atopic DermatitisNCT05062213
A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion in Adults of Atopic Dermatitis.
A study testing Moisturizer Body Lotion in people with Atopic Dermatitis, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.
Trial summary
This study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Moisturizer Body Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2021to 4 May 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
- Fitzpatrick Skin Type I to VI;
- Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting areas with AD craracteristic dryness at the initial visit;
- Generally in good health based on medical history reported by the subject;
- Able to read, write, speak and understand Portuguese;
- Person who signed the Consent for Photograph Release and Informed Consent Form;
- Person who agrees to change their leave on body moisturizers to the product of this study, and agrees to use it throughout the test period;
- Intends to complete the study and is willing and able to follow all study instructions.
Who cannot join
- Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
- Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
- Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
- Perform phototherapy;
- Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic / health care and hygiene products;
- Subject who has used other leave on moisturizers in the test areas (body and face), with the exception of investigational products, and/or who has changed their hygiene products during the study;
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- Has known allergies or adverse reactions to common topical skincare products;
- Present a skin condition that may influence the outcome of the study (e.g., psoriasis, active skin cancer, etc);
- Present skin lesions (e.g., ulcers, vesicles) or tattoos in the test areas, with the exception of lesions associated with mild or moderate atopic dermatitis;
- 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:
- Immunosuppressive drugs within 2 months before Visit 1; Immunobiological drugs within 2 months before visit 1; Topical anti-inflammatory steroids (corticosteroids) within 15 days before the visit 1; Topical and systemic immunomodulators (such as Tacrolimus and Pimecrolimus) within 15 days before visit 1; Topical and systemic antibiotics 15 days before the visit 1; Non-steroidal anti-inflammatory drugs within 15 days before Visit 1 ; Antihistamines within 2 weeks before Visit 1;
- Is self-reported to be pregnant or planning to become pregnant during the study;
- 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;
- Participating simultaneously in another study;
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor;
- History of a confirmed Coronavirus disease (COVID-19) in the past 30 days;
- Contact with a person infected with COVID-19 within 14 days prior to inclusion;
- Any international travel within 14 days of inclusion, including members of the same family;
- Subjects with self-reported symptoms in the past 2 weeks: unexplained cough, shortness of breath / difficulty breathing, fatigue, body aches (headaches, muscle aches, stomach pains), conjunctivitis, loss of smell, loss of taste, lack of appetite, nausea, vomiting, diarrhea, palpitations, fever or pain / tightness in the chest; temperature ≥ 38.0 degrees Celsius/100.4 degrees Fahrenheit measured; use of fever reducers within the last 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: Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion During and After 21 ± 2 Days of Use in Adults With Atopic Dermatitis.
This study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. Participants will receive the product to use it at home for 21 +/- 2 days.
- Conditions
- Atopic Dermatitis
- Being tested
- Moisturizer Body Lotion
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizer Body LotionOther
Also called The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.
Moisturizer Body Lotion
| Study group | Role | What they receive |
|---|---|---|
| Moisturizer Body Lotion | Experimental | All participants will receive the product and use it at home. Receives: Other: Moisturizer Body Lotion |
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 body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Measured: 21 ± 2 days
Change from baseline of the scores of peeling to 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified peelings 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
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 body (including face) 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
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 body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
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: Up to 21 ± 2 days
Change from baseline of scores of erythema to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Measured: 5 ± 1 days
Change from baseline of the scores of peeling to 5 ± 1 days
At baseline and at 5 ± 1 days days, the study physician will evaluate the whole body (including face) and score the identified peelings 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Measured: 5 ± 1 days
Change from baseline of the scores of blistering to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Measured: 5 ± 1 days
Change from baseline of the scores of edema to 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Measured: 5 ± 1 days
Secondary outcomes (25)
Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at baseline and 21 ± 2 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 21 ± 2 days
Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at baseline and 5 ± 1 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 5 ± 1 days
Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Atopic dermatitis (AD) severity based on SCORAD Index will be reported at 5 ± 1 days and 21 ± 2 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition.
This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
Skin hydration level of areas with and without AD characteristic dryness 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 moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD characteristic dryness
Skin hydration level of areas with and without AD characteristic dryness 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 moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
Skin hydration level of areas with and without AD characteristic dryness 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 moisturizer body lotion on skin hydration of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Skin barrier integrity of areas with and without AD characteristic dryness will be evaluated using 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 moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Skin barrier integrity of areas with and without AD characteristic dryness will be evaluated using 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 moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Skin barrier integrity of areas with and without AD characteristic dryness will be evaluated using 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 moisturizer body lotion on skin barrier of the study population after a period of use.
Measured: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 21 ± 2 days
Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 7 days
Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing AD and monitoring aspects of the disease that are important to participants with AD. This tool consists in a questionnaire responded by the participants with questions related to seven AD symptoms (itchy skin, sleep disturbance, bleeding skin, skin weeping/oozing, skin flaking, skin cracking, skin dryness/roughness). Participants must respond each questions specifying how many times per week the symptoms occur using the options: none day; 1 to 2 days; 3 to 4 days; 5 to 6 days; every day. Then each response receives the one of the following scores:
0 = no days;
1= 1-2 days; 2 = 3-4 days; 3 = 5-6 days 4= every day. In the end, a total score is calculated by the sum of the 7 items (rating from 0 to 28). Higher scores correlates to a more severe AD condition.
This measure will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.
Measured: 14 days
Perceived Efficacy of the quality of life at baseline
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the impact of AD in the quality of life. Participants will answer each question using the following qualitative scale: Affected very much; moderately affected; affected a little; did not affected.
This questionnaire will be used to evaluate the impact of AD in the quality of life before investigational product "Moisturizer body lotion" is used. The responses for each questions will be provided as percentages.
Measured: Baseline
Perceived Efficacy in the quality of life at 7 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 7 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product. The responses for each questions will be provided as percentages.
Measured: 7 days
Perceived Efficacy in the quality of life at 14 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 14 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product. The responses for each questions will be provided as percentages.
Measured: 14 days
Perceived Efficacy in the quality of life at 21 ± 2 days
Perceived efficacy related to the quality of life will be subjectively evaluated by the participants through a questionnaire with questions related to the improvement in the quality of life after 21 ± 2 days of moisturizer body lotion usage. Participants will answer each question using the following qualitative scale: Helped very much; moderately helped; helped a little; did not helped.
This questionnaire will be used to evaluate the impact of the moisturizer body lotion in the quality of life after periods of use of this product. The responses for each questions will be provided as percentages.
Measured: 21 ± 2 days
Perceived Efficacy of the moisturizer body lotion at 7 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree nor disagree; disagree; totally disagree.
The responses for each questions will be provided as percentages.
Measured: 7 days
Perceived Efficacy of the moisturizer body lotion at 14 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree nor disagree; disagree; totally disagree.
The responses for each questions will be provided as percentages.
Measured: 14 days
Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
Perceived efficacy related to the attributes of moisturizer body lotions will be subjectively evaluated by the participants through a questionnaire using the following qualitative scale: totally agree; agree; neither agree nor disagree; disagree; totally disagree.
The responses for each questions will be provided as percentages.
Measured: 21 ± 2 days
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at baseline
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD characteristic dryness, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area.
This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use.
Measured: Baseline
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at 21 ± 2 days
Skin microbiome is a group of microorganisms, including bacteria, present on the skin surface and plays an important role in AD. To evaluate the type and number of bacteria present on the surface of areas with and without AD characteristic dryness, a sample will be collected on this areas using a swab. The evaluation will be done through metagenomics, a technique that allows the determination of the types and quantity of bacteria present in an specific area.
This assessment will be used to determine the effect of the moisturizer body lotion on skin microbiome after a period of use.
Measured: 21 ± 2 days
Visual skin condition of areas with and without AD characteristic dryness at baseline captured photographically
Images of areas with and without AD characteristic dryness will be captured through a professional camera at baseline to visualize the skin condition of these areas before the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: Baseline
Visual skin condition of areas with and without AD characteristic dryness at 5 ± 1 days captured photographically
Images of areas with and without AD characteristic dryness will be captured through a professional camera at 5 ± 1 days to visualize the skin condition of these areas after the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: 5 ± 1 days
Visual skin condition of areas with and without AD characteristic dryness at 21 ± 2 days captured photographically
Images of areas with and without AD characteristic dryness will be captured through a professional camera at 21 ± 2 days to visualize the skin condition of these areas after the use of moisturizer body lotion.
No analysis is planned. These images will be used as a qualitative complement to the other results for moisturizer body lotion.
Measured: 21 ± 2 days
Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days
A testimonial regarding the experience with moisturizer body lotion will be provided by the participants through an open question at the end of the study. The purpose is to know their opinion and experience using this product during the study.
Measured: 21 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Nov 2021
- Primary completion4 May 2022
- Study completion4 May 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 Atopic DermatitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariane M Mosca, Bsc, Principal investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062213
- Sponsor's protocol ID
- CCSSKA004236
- Other IDs
- CCSSKA004236
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2021
- Last updated
- 13 Mar 2024
- 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
Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
PubMed 31166406Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
PubMed 19478181Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
PubMed 21697881Stamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries
Brazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
Pan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
PubMed 2459872Agner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
Chow SH, Shao J, Wang H. Sample Size Calculation in Clinical Research. 2ª Edição. Taylor and Francis Group, LLC, 2008.
Capone K, Kirchner F, Klein SL, Tierney NK. Effects of Colloidal Oatmeal Topical Atopic Dermatitis Cream on Skin Microbiome and Skin Barrier Properties. J Drugs Dermatol. 2020 May 1;19(5):524-531.
PubMed 32484623Howells L, Ratib S, Chalmers JR, Bradshaw L, Thomas KS; CLOTHES trial team. How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods. Br J Dermatol. 2018 May;178(5):1135-1142. doi: 10.1111/bjd.16367. Epub 2018 Apr 17.
PubMed 29355894Seite S, Flores GE, Henley JB, Martin R, Zelenkova H, Aguilar L, Fierer N. Microbiome of affected and unaffected skin of patients with atopic dermatitis before and after emollient treatment. J Drugs Dermatol. 2014 Nov;13(11):1365-72.
PubMed 25607704
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion During and After 21 ± 2 Days of Use in Adults With Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT05062213
- Acronym / sponsor ID
- CCSSKA004236
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 30 Sep 2021 (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 study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. Participants will receive the product to use it at home for 21 +/- 2 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moisturizer Body Lotion | Experimental | Other: Moisturizer Body LotionAll participants will receive the product and use it at home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fitzpatrick Skin Type I to VI;
- Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting areas with AD craracteristic dryness at the initial visit;
- Generally in good health based on medical history reported by the subject;
- Able to read, write, speak and understand Portuguese;
- Person who signed the Consent for Photograph Release and Informed Consent Form;
Key exclusion criteria (20 listed)
- Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
- Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
- Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
- Perform phototherapy;
- Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic / health care and hygiene products;
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 |
|---|---|---|
| Moisturizer Body LotionAlso: The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.Moisturizer Body Lotion | Other | Moisturizer Body Lotion |
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 body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of peeling to 21 ± 2 days
Time frame: 21 ± 2 days
At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified peelings 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
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 body (including face) 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
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 body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Percentage of participants with Adverse Events through 21 ± 2 days
Time frame: Up to 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.
Change from baseline of scores of erythema to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of peeling to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days days, the study physician will evaluate the whole body (including face) and score the identified peelings 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of blistering to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) 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 body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
Change from baseline of the scores of edema to 5 ± 1 days
Time frame: 5 ± 1 days
At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including 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 this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.
25 secondary outcomes
Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Time frame: 21 ± 2 days
Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)
Time frame: 5 ± 1 days
Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
Time frame: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD characteristic dryness
Time frame: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Time frame: 21 ± 2 days
Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Time frame: 5 ± 1 days
Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
Time frame: 5 ± 1 days to 21 ± 2 days
Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 21 ± 2 days
Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 7 days
Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
Time frame: 14 days
Perceived Efficacy of the quality of life at baseline
Time frame: Baseline
Perceived Efficacy in the quality of life at 7 days
Time frame: 7 days
Perceived Efficacy in the quality of life at 14 days
Time frame: 14 days
Perceived Efficacy in the quality of life at 21 ± 2 days
Time frame: 21 ± 2 days
Perceived Efficacy of the moisturizer body lotion at 7 days
Time frame: 7 days
Perceived Efficacy of the moisturizer body lotion at 14 days
Time frame: 14 days
Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
Time frame: 21 ± 2 days
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at baseline
Time frame: Baseline
Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at 21 ± 2 days
Time frame: 21 ± 2 days
Visual skin condition of areas with and without AD characteristic dryness at baseline captured photographically
Time frame: Baseline
Visual skin condition of areas with and without AD characteristic dryness at 5 ± 1 days captured photographically
Time frame: 5 ± 1 days
Visual skin condition of areas with and without AD characteristic dryness at 21 ± 2 days captured photographically
Time frame: 21 ± 2 days
Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days
Time frame: 21 ± 2 days
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 13 Mar 2024.
- Background: PubMed 31166406Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
- Background: PubMed 19478181Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Background: PubMed 21697881Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
- BackgroundStamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries
- BackgroundBrazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
- BackgroundPan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
- Background: PubMed 2459872Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
- BackgroundAgner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
- BackgroundChow SH, Shao J, Wang H. Sample Size Calculation in Clinical Research. 2ª Edição. Taylor and Francis Group, LLC, 2008.
- Results publication: PubMed 32484623Capone K, Kirchner F, Klein SL, Tierney NK. Effects of Colloidal Oatmeal Topical Atopic Dermatitis Cream on Skin Microbiome and Skin Barrier Properties. J Drugs Dermatol. 2020 May 1;19(5):524-531.
- Results publication: PubMed 29355894Howells L, Ratib S, Chalmers JR, Bradshaw L, Thomas KS; CLOTHES trial team. How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods. Br J Dermatol. 2018 May;178(5):1135-1142. doi: 10.1111/bjd.16367. Epub 2018 Apr 17.
- Results publication: PubMed 25607704Seite S, Flores GE, Henley JB, Martin R, Zelenkova H, Aguilar L, Fierer N. Microbiome of affected and unaffected skin of patients with atopic dermatitis before and after emollient treatment. J Drugs Dermatol. 2014 Nov;13(11):1365-72.
- Single-center, Open-label, Non-randomized Clinical Study to Assess the Safety and Efficacy of a Moisturizing Lotion During and After 21 ± 2 Days of Use in Adult Subjects with Atopic DermatitisLink provided by the sponsor.
- 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.
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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 M 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 Moisturizer Body Lotion in people with Atopic Dermatitis, 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 7 inclusion and 20 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 13 Mar 2024. 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 9 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 NCT05062213, 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 13 Mar 2024.