In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With … (NCT07194408) | Clinical Trial Compass
CompletedNot Applicable
In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis
Mauritius22 participantsStarted 2023-12-12
Plain-language 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-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric controls.
Who can participate
Age range3 Years – 11 Years
SexALL
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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…
What they're measuring
1
Global tolerance assessment by the investigator
Timeframe: At the end of the study, after Last Patient Out, (after Day 22)