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 range
18 Years – 45 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:
* 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 …
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
1
Global tolerance assessment by the investigator
Timeframe: At the end of the study, after Last Patient Out, (after Day 22)