In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin

Pierre Fabre

Status: Completed

Conditions: Atopic Dermatitis (AD); SCORAD Index(15-25)

Treatments: Other: Sunscreen RV4620A RP2552

Study type: Observational

Funder types: Industry

Identifiers

NCT07194421

RV4620A20230439

Details and patient eligibility

About

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)

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

42 participants in 1 patient group

Test group

Description:

Adult intended to use Sunscreen RV4620A RP2552 product

Treatment:

Other: Sunscreen RV4620A RP2552