Status:
COMPLETED
In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Atopic Dermatitis (AD)
SCORAD Index (15-25)
Eligibility:
All Genders
3-11 years
Brief Summary
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-spectru...
Detailed Description
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: T...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Criteria related to the population:
- phototype: I to IV;
- face and body skin type: all skin types;
- subjects must be registered with health social security or health social insurance (if required by national regulations);
- subjects' parent(s)/ legal representatives having signed their written Informed Consent form for their participation in the study and a photograph authorization;
- subjects' parent(s)/ legal representatives certifying the truth of the personal information declared to the Investigator;
- Health Status: Considered a "healthy subject" by the Investigators (excluding SCORAD considerations).
- 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:
- Subjects who have participated in another clinical trial within the week before the inclusion visit, or for a longer period if deemed necessary by the Investigator.
- Subjects currently participating or planning to participate in another clinical trial during the study, either in the same or a different investigation center.
- Criteria Related to Subject's Health:
- Subjects experiencing a flare of atopic dermatitis.
- Subjects with dermatological conditions that may interfere with study data or are considered hazardous by the Investigator (e.g., pityriasis versicolor, severe pigmentation disorders such as vitiligo, melasma, multiple lentigines, numerous or large congenital nevi).
- Subjects with a personal medical history that may interfere with study data or is incompatible with study requirements (except if required by the Sponsor, e.g., atopic dermatitis).
Exclusion
Key Trial Info
Start Date :
December 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07194408
Start Date
December 12 2023
End Date
February 16 2024
Last Update
September 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Insight Research
Quatre Bornes, Mauritius, Mauritius, 72218