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Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks
Sponsor: Pierre Fabre Dermo Cosmetique
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)
Official title: Open-label Study to Assess the Tolerance and Efficacy of the Product RV4421B-EV0407, Applied in Paediatric and Adult Populations With Mild to Moderate Atopic Dermatitis for 12 Weeks
Key Details
Gender
All
Age Range
3 Months - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2025-09-29
Completion Date
2026-07-31
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
RV4421B- EV0407
Medical device. Product application on studied areas, 5 to 15 minutes after corticosteroids application, if applicable. The maximum duration of application of medical device is 87 days.