Actively Recruiting

Phase Not Applicable
Age: 3Months +
All Genders
NCT07014007

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

Led by Pierre Fabre Dermo Cosmetique · Updated on 2026-05-05

105

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 3Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female of any skin type according to Fitzpatrick classification
  • Infants aged 3 months to 23 months included
  • Children aged 24 months to 12 years included
  • Teenagers and adults aged 13 years and older
  • Diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria
  • Eczema and dry skin areas covering up to 30% of the body surface
  • Mild to moderate atopic dermatitis
  • Using topical corticosteroids on affected areas for 1 to 5 days before inclusion and ongoing at inclusion (investigator may adjust treatment during study)
Not Eligible

You will not qualify if you...

  • Infants with eczema or dry skin areas located on the diaper area (groups 1 and 2)
  • History of allergy or intolerance to any ingredients of the study product or research materials
  • Any other skin condition or characteristics on studied areas that could interfere with assessments
  • Any dermatological, acute, chronic, or progressive disease that may interfere with study data or pose risk
  • Known AIDS or infectious diseases (acute or chronic)
  • Use of systemic biological immunosuppressive treatment within 12 weeks before inclusion or planned during study
  • Phototherapy within 4 weeks before inclusion or planned during study
  • Use of systemic non-biological immunosuppressive treatment within 4 weeks before inclusion or planned during study
  • Use of systemic corticosteroids within 4 weeks before inclusion or planned during study
  • Use of systemic antibiotics for skin conditions within 2 weeks before inclusion or planned during study
  • Use of systemic antihistamines within 2 weeks before inclusion
  • Use of certain topical treatments on studied areas within 1 week before inclusion or planned during study
  • Use of any other topical product incompatible with or interfering with the study on studied areas
  • Use of skin care products on whole body between evening before visit and inclusion
  • Use of water or cleansing products on whole body within 4 hours before inclusion (light face wash allowed if no facial study areas)
  • Plans to change usual moisturizer or care habits during the study
  • For breastfed subjects in groups 1 and 2, mother’s use of systemic immunosuppressive, corticosteroid, antihistaminic, or antibiotic treatments within specified times before inclusion or planned during study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Insight Research Ltd

Quatre Bornes, Mauritius, Mauritius, 742CU001

Actively Recruiting

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Research Team

A

Adeline Bacquey

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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