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 range

3 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global tolerance assessment by the investigator

Timeframe: At the end of the study, after Last Patient Out, (after Day 22)

Trial details

NCT IDNCT07194408

SponsorPierre Fabre Dermo Cosmetique

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-16

View on ClinicalTrials.gov More Atopic Dermatitis (AD) trials