NCT07194421Completed
In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 42 (actual)
- First submitted
- 11 Sept 2025
- Start date
- 10 Oct 2023
- Primary completion date
- 9 Feb 2024
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07194421
What you commit to
- Study type: Observational
- Participants enrolled: 42
- From 10 Oct 2023 to the primary completion date, 9 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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).
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Insight Research Coordinator of this site? Confirm its status | Quatre Bornes | Mauritius | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.