NCT07014007

Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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)

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-09-29
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-06-10
• Last updated: 2025-09-04