An observational study in Atopic Dermatitis (AD) and SCORAD Index(15-25), sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Mauritius. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Observational
This study evaluates a broad-spectrum SPF50+ sunscreen on 42 adults with Atopic Dermatitis, measuring skin tolerance and barrier function.
The study includes several visits as follow :
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 42 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.
Inclusion Criteria:
Criteria Related to Skin Condition:
Non-Inclusion Criteria:
Criteria Related to Population:
Criteria Related to Subject's Health:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult intended to use Sunscreen RV4620A RP2552 product
Other: Sunscreen RV4620A RP2552
Dermo-cosmetic product, Broadspectrum Sunscreen RV4620A RP2552, very high protection product Instructions for product use given to the subjects: Apply before and during sun exposure, at least twice daily. During sun exposure, applications must be renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, apply the product in the morning and at the beginning of the afternoon.
Global tolerance assessment by the investigator
Global tolerance of the product is assessed on the "tolerance population" which includes all the subjects who applied investigational product at least once. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
Time frame: At the end of the study, after Last Patient Out, (after Day 22)
Evaluation Cosmetic Acceptability of the Sunscreen RV4620A - RP2552
The subjects answer a 10-questions questionnaire about user satisfaction, texture, and overall experience with the product, providing insights into its appeal and usability.
Time frame: Visit 3 (Day 22)
Evaluation of Irritative Factors with Sunscreen RV4620A - RP2552
The subjects answer a questionnaire regarding the irritative factors
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
Evaluation of Transepidermal Water Loss with Sunscreen RV4620A - RP2552
Trans Epidermal Water Loss measurements are done with a Tewameter TM 300® by a trained technician in a room with controlled temperature and hygrometry. This measurement aims to assess the effect of the investigational product on transepidermal water loss to determine the product's impact on the skin's barrier function.
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
Assessment of Skin pH with Sunscreen RV4620A - RP2552
Measurement of the skin pH is done using the COURAGE \& KHAZAKA PH 900 PC Skin pH meter fitted with an Ingold electrode. The goal is to determine the product's respect of skin surface pH.
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
Assessment of the Lipidic Index Evolution with Sunscreen RV4620A - RP2552
The quantity of sebum excreted to the skin surface is quantitatively evaluated with a Sebumeter SM 815 (Courage \& Khazaka). The goal is to determine the product's respect of skin's barrier function and seboregulating effect
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
Ran from Oct 2023 to primary completion in Feb 2024, 3 months.
Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's 3 months is below that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pierre Fabre Dermo Cosmetique →