Study of RV4421B-EV0407 Cream for Mild to Moderate Atopic Dermatitis in Infants, Children, Teens, and Adults Over 12 Weeks

What this Trial Is About

Researchers are evaluating the medical device cream RV4421B-EV0407 for the treatment of various types of eczema, including atopic eczema, contact eczema, and chronic hand eczema. This study involves a diverse group of adults and children, including those with darker skin tones, to assess the safety and efficacy of the cream used alone or alongside topical corticosteroids over a period of 12 weeks with an additional follow-up. Participants will apply the product twice daily, either by itself or with topical corticosteroid therapy, depending on their age group. The study includes three groups infants 3 months to 23 months, children 24 months to 12 years, and teenagers and adults 13 years and older. The product application period lasts up to 87 days. During the study, participants will attend five visits an inclusion visit on day 1, two intermediate visits including one by phone between days 8 and 15 and one on day 29, another visit on day 57, and a final visit on day 85. Researchers will monitor local tolerance to the product, adverse events, and atopic dermatitis severity using various assessments. Quality of life questionnaires and satisfaction surveys will also be completed, with continuous monitoring throughout the study period.

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