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

Sponsor
Pierre Fabre Dermo Cosmetique
Study ID
NCT07014007
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • RV4421B- EV0407 — DEVICE
    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.

Study Details

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)

Key Dates

First listed
Jun 10, 2025
Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Infant group
    Subjects aged from 3 months to 23 months old included Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids.
  • Experimental: Children group
    Subjects aged from 24 months to 12 years old included Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids.
  • Experimental: Teenagers & adults group
    Subjects aged from 13 years old Medical device: RV4421B- EV0407 the test product will be applied twice daily alone or in association with topical corticosteroids.

Primary Outcome Measure

Local tolerance of the product RV4421B-EV0407 on studied areas [ Time Frame: Day 85 ]

Central Contacts

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