HealthyNCT05864417

A Study to Assess Effect of Two Facial Sunscreens in Improving Wrinkles, Fine Lines and Melasma in Adult Participants

A study testing Sunscreen Color tone 2.0 and Sunscreen Color tone 3.0 in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sunscreen Color tone 2.0 and Sunscreen Color tone 3.0
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBrazil
Study dates: 22 Mar 2023to 10 Jul 2023
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 35 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and/or Female
Participants of any ethnicity according to IBGE criteria
From 35 years of age
Fitzpatrick Skin Type II to IV
Participant presenting mild to moderate melasma (grade 1 to 2 - according to the Site's scale), proven by a dermatologist
Participant's presenting wrinkles/fine lines in any region of the face (periorbital, frontal and/or nasolabial) from grade 2 to 6 (according to the Site's scale), confirmed by the dermatologist

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Generally in good health based on medical history reported by the participant
Able to read, write, speak, and understand Portuguese
For Male Participants: agree to shave 24 hours before visits 1 to 4
Individual has signed the following informed consent documents (ICD):ICD, Informed Consent Image Disclosure (ICID) e Informed Consent for Cession of Rights for Image Use (ICCRIU)
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 sunscreen
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 (example scars, ulcers, vesicles) or tattoos on test sites
Participants with immune deficiency
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 or steroidal drugs within 2 months before Visit 1, 2; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 2 weeks before Visit 1

Show all 19Show fewer

Start or change of hormone replacement therapy or contraceptive drug method in the last 03 months
Participants who are using or have used topical products such as Retin-A, Retin-A Micro, and Differin or any other topical retinoid on the face within 6 months prior to the study; or use of any oral retinoid within 1 year prior to the study
Participants who are using or have currently used any facial products containing active ingredients against spots and/or wrinkles: alpha or beta hydroxy acids (including salicylic acid), polyhydroxy acids, topical products containing retinol or retinol derivatives, hydroquinones, arbutin, niacinamide, N-acetylglucosamine, Thiamidol, kojic acid, azelaic acid, licorice extract, whitening peptides, vitamin C or any other 'anti-aging' products or products capable of interfering with skin brightness/uniformity, or with spots, within 2 months prior to the start of the study
Participants who have used cosmetic products on the same area (face) with anti-spot and anti-wrinkle action, within 14 days before the beginning of the study
Participants who have undergone chemical and/or physical peeling, laser or similar aesthetic treatments within 6 months prior to the study
Participants who have undergone invasive cosmetic or dermatological treatment in the test area within 2 months before the start of the study or during the study
Intense sun exposure or tanning session up to 01 month before the initial evaluation or planned intense sun exposure or tanning session during the study
Present signs of intense tanning, according to the evaluation of the study physician
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
Present excessive hair in the evaluation region that may interfere in the instrumental measurements. In the case of men, even in the presence of excessive hair in the beard region, they will be instructed to shave one day before the visit
Is simultaneously participating in any other clinical study;
Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791

Other trials in Brazil

About this study

Official title: A Single-Center, Open-Label, Safety in Use Clinical Study to Assess Topical Tolerability and Efficacy in Improving Wrinkles, Fine Lines, and Melasma After 84 ± 2 Days of Use of Two Facial Sunscreens in Adult Participants

The purpose of this study is to evaluate the topical safety (tolerability/acceptability) and efficacy of two facial sunscreen in improving wrinkles, fine lines and melasma after 84 +/- 2 days of use under normal conditions on the face by adult participants. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (assessment of color intensity and size of melasma spots and assessment of wrinkles and fine lines), facial imaging, and self-perceived efficacy through subjective questionnaire and quality of life questionnaires (MELASQol) will be evaluated, as well as an open emotional statement written by the participant at the end of use experience".

Conditions: Healthy
Being tested: Sunscreen Color tone 2.0, Sunscreen Color tone 3.0

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sunscreen Color tone 2.0Other
Participants will topically apply sunscreen color tone 2.0.
Sunscreen Color tone 3.0Other
Participants will topically apply sunscreen color tone 3.0.

Study groups in NCT05864417
Study group	Role	What they receive
Sunscreen	Experimental	Participants will choose one facial sunscreen (SPF 70) out of the two (one with a light tone [Color 2.0] and another with a medium tone [Color 3.0]) based on the tone that best suits their skin color. At home, they will apply a generous amount of facial sunscreen to the face twice daily and will reapply when they feel the need up to 84 + (-) 2 days. Receives: Other: Sunscreen Color tone 2.0; Other: Sunscreen Color tone 3.0

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events
Number of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Measured: Up to 84 +/- 2 days
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 28
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's least significant difference (LSD) multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate individual topology angle (ITA). The lighter the skin, the higher the ITA.
Measured: Baseline and Day 28
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 56
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's LSD multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate ITA (individual topology angle). The lighter the skin, the higher the ITA.
Measured: Baseline and Day 56
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 84 +/- 2
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's LSD multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate ITA (individual topology angle). The lighter the skin, the higher the ITA.
Measured: Baseline and Day 84 +/- 2
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 28
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Measured: Baseline and Day 28
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 56
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Measured: Baseline and Day 56
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 84 +/- 2
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Measured: Baseline and Day 84 +/- 2
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 28
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Measured: Day 28
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 56
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Measured: Day 56
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 84 +/- 2
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Measured: Day 84 +/- 2
Participant's Self-perceived Questionnaire to Assess their Perception of the Color/Tone of Sunscreen
Participants will apply the investigational products on their faces, one product on each half-face to see how the color of each product will look in relation to their skin tone, and then choose the product that best suits their skin color.
Measured: Baseline (Day 1)
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 3 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Measured: Day 28
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 84 +/- 2
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 84 +/- 2 will be reported. Participants will answer 14 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Measured: Day 84 +/- 2
Testimonial Regarding the Experience with Sunscreen
A testimonial regarding the experience with sunscreen 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: End of the Study (84 +/- 2 days)
Topical Tolerability as Assessed by the Dermatologist
Topical tolerability will be assessed using skin reaction intensity evaluation scale. Skin Reaction Intensity Evaluation Scale is a composite evaluation of any irritation/reaction subscoring for erythema, peeling, vesiculation, and edema. The scale ranges from 0=absent to 4=intense.
Measured: Up to 84 +/- 2 days
Number of Participants with Improvement From Baseline in Melasma by mMASI Scale as Assessed by the Dermatologist
The modified mMASI scale (Area and Severity Index) will be used. The evaluation is performed under standard lighting (day light). The modified mMASI scale score is calculated by subjectively assessing two factors: area of involvement (A) and darkening (D), with the forehead (f), right malar region (rm), left malar region (lm), and chin (c), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. The grading range is from 0 to 24, and the area of involvement (A) and darkening (D) are graded as described below:Area of Involvement (A): 0= absent, 1 = <10%, 2 = 10%-29%, 3 = 30%-49%, 4 = 50%-69%, 5 = 70%-89%, 6 = 90%-100% and Darkening (D):0= absent, 1 = very light, 2 = light, 3= significantly, 4 = severe.
Measured: Up to 84 +/- 2 days
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 28
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition.
Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).
Measured: Day 28
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 56
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition.
Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).
Measured: Day 56
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 84 +/- 2
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition.
Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).
Measured: Day 84 +/- 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202310 Jul 2023

First posted18 May 2023
Study start22 Mar 2023
Primary completion10 Jul 2023
Study completion10 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05864417
Sponsor's protocol ID: CCSSKA005235
Other IDs: CCSSKA005235
Status last verified: Aug 2023
First submitted: 9 May 2023
Last updated: 16 Aug 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Open-Label, Safety in Use Clinical Study to Assess Topical Tolerability and Efficacy in Improving Wrinkles, Fine Lines, and Melasma After 84 ± 2 Days of Use of Two Facial Sunscreens in Adult Participants
ClinicalTrials.gov ID: NCT05864417
Acronym / sponsor ID: CCSSKA005235
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 22 Mar 2023 (actual)
Primary completion: 10 Jul 2023 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 18 May 2023 (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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sunscreen	Experimental	Other: Sunscreen Color tone 2.0, Other: Sunscreen Color tone 3.0Participants will choose one facial sunscreen (SPF 70) out of the two (one with a light tone [Color 2.0] and another with a medium tone [Color 3.0]) based on the tone that best suits their skin color. At home, they will apply a generous amount of facial sunscreen to the face twice daily and will reapply when they feel the need up to 84 + (-) 2 days.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male and/or Female
Participants of any ethnicity according to IBGE criteria
From 35 years of age
Fitzpatrick Skin Type II to IV
Participant presenting mild to moderate melasma (grade 1 to 2 - according to the Site's scale), proven by a dermatologist

Key exclusion criteria (19 listed)

Has known allergies or adverse reactions to common topical skincare products including sunscreen
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 (example scars, ulcers, vesicles) or tattoos on test sites
Participants with immune deficiency
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
Sunscreen Color tone 2.0Participants will topically apply sunscreen color tone 2.0.	Other	Sunscreen
Sunscreen Color tone 3.0Participants will topically apply sunscreen color tone 3.0.	Other	Sunscreen

Primary outcome

Number of Participants with Adverse Events
Time frame: Up to 84 +/- 2 days
Number of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 28
Time frame: Baseline and Day 28
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's least significant difference (LSD) multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate individual topology angle (ITA). The lighter the skin, the higher the ITA.
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 56
Time frame: Baseline and Day 56
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's LSD multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate ITA (individual topology angle). The lighter the skin, the higher the ITA.
Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 84 +/- 2
Time frame: Baseline and Day 84 +/- 2
Melasma color intensity will be measured using chroma meter. Measurements will be performed both in area with melasma chosen by dermatologist, as documented in CRF during the eligibility assessment, and in an adjacent region (without the presence of melasma). Statistical improvement will be measured as (reduction in value of "b" parameter and increase in value of "L" and ITA parameters) versus baseline (D1) and Day 28 by an Anova model followed by Fisher's LSD multiple comparison test. The color space L *, a *, b * was developed as a method of expressing colors in terms of numbers. The color space corresponds to perceived color characterization. L * stands for brightness (100 corresponds to white and 0 corresponds to black and b * indicates blue-yellow coloration. By determining values L * and b * of a color, it is possible to calculate ITA (individual topology angle). The lighter the skin, the higher the ITA.
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 28
Time frame: Baseline and Day 28
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 56
Time frame: Baseline and Day 56
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 84 +/- 2
Time frame: Baseline and Day 84 +/- 2
Facial images will be captured using the Visia CR Facial Imaging Booth. Three images per participant will be captured: right lateral, left lateral and frontal using the Standard 1, Standard 2, Cross Polarized and RBX (Brown) filters.The captured images will be further analyzed using specific image analysis software to evaluate the intensity and size of melasma, and wrinkles and fine lines.
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 28
Time frame: Day 28
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 56
Time frame: Day 56
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 84 +/- 2
Time frame: Day 84 +/- 2
The MELASQol assesses the effect melasma has on the quality of life of sufferers on a scale of 1-10, where 1=not bothered at all, 2=not bothered most of the time,3=not bothered sometimes,4= neutral,5=sometimes bothered,6=Mostly bothered and 7=bothered all the time to 7 (bothered all of the time) rating the 10 questions. A total score is generated which ranges from 10 to 70. The lower the score, the better the participant's quality of life.
Participant's Self-perceived Questionnaire to Assess their Perception of the Color/Tone of Sunscreen
Time frame: Baseline (Day 1)
Participants will apply the investigational products on their faces, one product on each half-face to see how the color of each product will look in relation to their skin tone, and then choose the product that best suits their skin color.
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
Time frame: Day 28
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 3 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 84 +/- 2
Time frame: Day 84 +/- 2
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 84 +/- 2 will be reported. Participants will answer 14 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Testimonial Regarding the Experience with Sunscreen
Time frame: End of the Study (84 +/- 2 days)
A testimonial regarding the experience with sunscreen 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.
Topical Tolerability as Assessed by the Dermatologist
Time frame: Up to 84 +/- 2 days
Topical tolerability will be assessed using skin reaction intensity evaluation scale. Skin Reaction Intensity Evaluation Scale is a composite evaluation of any irritation/reaction subscoring for erythema, peeling, vesiculation, and edema. The scale ranges from 0=absent to 4=intense.
Number of Participants with Improvement From Baseline in Melasma by mMASI Scale as Assessed by the Dermatologist
Time frame: Up to 84 +/- 2 days
The modified mMASI scale (Area and Severity Index) will be used. The evaluation is performed under standard lighting (day light). The modified mMASI scale score is calculated by subjectively assessing two factors: area of involvement (A) and darkening (D), with the forehead (f), right malar region (rm), left malar region (lm), and chin (c), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. The grading range is from 0 to 24, and the area of involvement (A) and darkening (D) are graded as described below:Area of Involvement (A): 0= absent, 1 = <10%, 2 = 10%-29%, 3 = 30%-49%, 4 = 50%-69%, 5 = 70%-89%, 6 = 90%-100% and Darkening (D):0= absent, 1 = very light, 2 = light, 3= significantly, 4 = severe.
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 28
Time frame: Day 28
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition. Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 56
Time frame: Day 56
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition. Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).
Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 84 +/- 2
Time frame: Day 84 +/- 2
It is a clinical evaluation of the participant's face performed by a dermatologist according to a predefined scale. The attributes evaluated will be: wrinkles, and fine lines. A 10-point ordinal scale (0 to 9) developed by study site will be used where 0 = Absent and 9 = Numerous.Therefore, because it is an ordinal scale, the points in between do not have an established definition. Dermatologists have been trained to evaluate and classify grades 1, 2, and 3 as "mild", grades 4, 5, and 6 as "moderate", and grades 7, 8, and 9 as "severe". Between these grades there is a small variation that is identified by the trained dermatologists, and which are taken into consideration to define the classification of the evaluated attribute (wrinkles/fine lines).

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 16 Aug 2023.
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.

Gabrielli Brianezi principal investigator

Johnson & Johnson Consumer Inc. (J&JCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sunscreen Color tone 2.0 and Sunscreen Color tone 3.0 in people with Healthy, 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 11 inclusion and 19 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 16 Aug 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?

Number of Participants with Adverse Events (time frame: Up to 84 +/- 2 days). The study lists 19 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 NCT05864417.

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 16 Aug 2023.