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 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Observational
Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited. This study evaluates a broad-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric controls.
Atopic dermatitis is a chronic skin condition that necessitates sun protection, yet there is limited research on the effectiveness of sunscreens and skin tolerance in Atopic Dermatitis.
Objectives: This study aims to evaluate the tolerance of a broad-spectrum SPF50+ sunscreen in children with Atopic Dermatitis, monitored through dermatological and pediatric assessments.
Methods: This study is conducted on 22 children with Atopic Dermatitis confirmed using the SCORAD index (15-25).
The protocol includes 2 visits and assessments as follow:
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 22 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 the population:
Criteria Related to Atopic Dermatitis:
- Subject must present atopic dermatitis according to the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis, with mild atopic dermatitis indicated by a SCORAD score of 15 to 25 (inclusive), determined by a dermatologist and a pediatrician together.
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.
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.
Children 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 is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. 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 Global Acceptability of the Sunscreen RV4620A - RP2552
The subjects' parent(s)/ legal representatives give their global appreciation about the product with positive and negative feedback. According to the items, the subjects' parent(s)/ legal representatives have to answer opened questions and a question using a scale from 0 to 10.
Time frame: Visit 3 (Day 22)
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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