Status:
COMPLETED
In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Atopic Dermatitis (AD)
SCORAD Index(15-25)
Eligibility:
All Genders
18-45 years
Brief 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: In...
Eligibility Criteria
Inclusion
- 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 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.
- Pregnant or breastfeeding women (for women of childbearing potential).
- 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 :
October 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07194421
Start Date
October 10 2023
End Date
February 9 2024
Last Update
September 26 2025
Active Locations (1)
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1
Insight Research
Quatre Bornes, Mauritius, Mauritius, 72218