In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic… (NCT07194421) | Clinical Trial Compass
CompletedNot Applicable
In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin
Mauritius42 participantsStarted 2023-10-10
Plain-language summary
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 :
* Visit 1: Inclusion (Day 1)
* Visit 2: Intermediate Visit (Day 8)
* Visit 3: End of Study (Day 22)
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Phototype: from I to VI.
* Sun Exposure: Adults anticipating at least 6 exposures of 2 hours each during the study.
* Swimming Sessions: Subjects planning at least 4 swimming sessions, with a minimum of 50% intending to swim twice in the sea and twice in a pool.
* Sensitive Skin: At least 50% of subjects report having sensitive skin.
* Health Insurance: Must be registered with health social security or health insurance.
* Informed Consent: Must have signed the written Informed Consent form (ICF) for study participation.
* Personal Information: Must certify the accuracy of personal information provided to the Investigator.
* Health Status: Considered a "healthy subject" by the Investigator (excluding SCORAD considerations).
* Women of Childbearing Potential: Must agree to use an effective contraceptive method throughout the study and for at least 1 month prior to the inclusion visit.
Criteria Related to Skin Condition:
* 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.
* Reactivity: Must be reactive to external irritative factors such as chlorine, sand, salt, and sweat.
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 …
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)