Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatit… (NCT07014007) | Clinical Trial Compass
RecruitingNot Applicable
Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks
Mauritius105 participantsStarted 2025-09-30
Plain-language summary
Pierre Fabre Laboratories have developed a cream with medical device status, RV4421B-EV0407 indicated for the treatment of eczemas, including atopic eczema, contact eczema and chronic hand eczema.
This product is already marketed in several countries. The objective of this clinical study is to evaluate the safety and efficacy of the study product when used alone or in association with topical corticosteroid therapy, in an ethnically diverse adult and pediatric population (including dark skin) and over a long period of time with a 12-week follow-up.
5 visits are planned:
* Visit 1: Inclusion visit (Day 1)
* Visit 2: Intermediate visit (Phone visit - Between Day 8 and Day 15)
* Visit 3: Intermediate visit (Day 29 ± 3 days)
* Visit 4: Intermediate visit (Day 57 ± 3 days)
* Visit 5: End of study visit (Day 85 ± 3 days)
Who can participate
Age range
3 Months
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:
* Male or female, with any phototype according to Fitzpatrick classification aged:
* Group 1 (infants group): from 3 months to 23 months old included
* Group 2 (children group): from 24 months to 12 years old included
* Group 3 (teenagers \& adults group): from 13 years old
* Subject with a diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams HC, Burney PG, et al.).
* Subject with studied areas (lesions and prevailing xerotic areas) limited up to 30% of the body surface area
* Subject with mild to moderate Atopic Dermatitis
Criteria related to treatments and/or products:
• Topical corticosteroids treatments (following international treatment guidelines for each age sub-group and including investigator agreement) applied on AD lesions areas since 1 to 5 days before the inclusion and ongoing at the time of inclusion. \*
\*The investigator will be authorized to adjust the treatment during the study.
Exclusion criteria:
Criteria related to the skin condition or the disease:
* Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 \& 2)
* Subject with history of allergy or intolerance to any of the study product(s) ingredients or material used for the research
* Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo…) on the studied areas liable to interfere with the study assessments
* Subject ha…
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
Local tolerance of the product RV4421B-EV0407 on studied areas