Tests a cream device for eczema in children and adults
Tests a cream device in people with mild to moderate atopic dermatitis.
Plain-language title generated from the registry record
Registry title: Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks
Key facts
- Where
- Quatre Bornes, MauritiusSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies, children, teenagers and adults with mild to moderate atopic dermatitis who already use topical corticosteroids on their skin lesions. They test a cream for 12 weeks.
- Age
- From 3 months old, with no upper limit. Three groups: 3 to 23 months, 24 months to 12 years, and 13 years and older.
- Sex
- Both men and women (all sexes) can join.
- Disease stage
- Mild to moderate atopic dermatitis, diagnosed by the U.K. Working Party's criteria. The affected or very dry areas cover up to 30% of the body surface.
- Earlier treatment
- Must have used topical corticosteroids on the lesions for 1 to 5 days before joining, and still be using them. Recent other treatments can exclude a person, such as systemic corticosteroids within 4 weeks.
Main reasons for not taking part
- Atopic dermatitis or dry skin in the diaper area (infants and children)
- Allergy or intolerance to an ingredient of the study product
- Another skin condition, or a tattoo, on the studied areas that could disturb the assessments
- Known AIDS or an acute or chronic infectious disease
- Recent systemic immunosuppressive treatment, phototherapy, or systemic antibiotics for skin problems
Read by machine on 12 November 2026.
Where in Mauritius
- Insight Research LtdQuatre Bornes, MauritiusContact: Ashlam DOARIKATaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Pierre Fabre Dermo Cosmetique
- Trial code
- NCT07014007
- Record updated
- 5 May 2026
- Original description
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.Read full original descriptionShow less
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
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)
Inclusion: Male or female, with any phototype according to Fitzpatrick classification aged:; Group 1 (infants group): from 3 months to 23 months old included; Group 2 (children group): from 24 months to 12 years old included; Group 3 (teenagers \& adults group): from 13 years old; Subject with a diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams HC, Burney PG, et al.); Subject with studied areas (lesions and prevailing xerotic areas) limited up to 30% of the body surface area; Subject with mild to moderate Atopic Dermatitis; Criteria related to treatments and/or products:; Topical corticosteroids treatments (following international treatment guidelines for each age sub-group and including investigator agreement) applied on AD lesions areas since 1 to 5 days before the inclusion and ongoing at the time of inclusion. *; *The investigator will be authorized to adjust the treatment during the study.
Exclusion: Systemic biological immunosuppressive treatment established or modified within 12 weeks before the inclusion or planned to be started during the study; Phototherapy performed within 4 weeks before the inclusion visit or planned to be started during the study; Systemic non-biological immunosuppressive treatment established or modified within 4 weeks before the inclusion or ongoing or planned to be started during the study; Systemic corticosteroids treatment established or modified within 4 weeks before the inclusion or ongoing or planned to be started during the study; Systemic antibiotics for dermatological purposes treatment established or modified within 2 weeks before the inclusion or ongoing or planned to be started during the study; Systemic antihistaminic treatment established or modified within 2 weeks before the inclusion; Topical treatments (immunomodulators (TIMs), non-steroidal anti-inflammatory, antihistaminic, antibiotics for dermatological purposes or antiseptics) applied on studied areas within 1 week before the inclusion or ongoing or planned to be started during the study; Any other topical treatment or product applied on studied areas incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study; Systemic biological immunosuppressive treatment established or modified within 12 weeks before the inclusion or planned to be started during the study; Systemic non-biological immunosuppressive treatment established or modified within 4 weeks before the inclusion or planned to be started during the study; Systemic corticosteroids established or modified within 2 weeks before the inclusion or planned to be started during the study; Systemic antihistaminic established or modified within 2 weeks before the inclusion; Systemic antibiotics for dermatological purposes established or modified within 1 week before the inclusion or planned to be started during the study; Criteria related to the skin condition or the disease:; Subject with history of allergy or intolerance to any of the study product(s) ingredients or material used for the research; Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo…) on the studied areas liable to interfere with the study assessments; Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements; Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute or chronic); Criteria related to treatments and/or products:; Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 \& 2); Skin care product (including moisturizer) applied on the whole body between the evening before the visit and the inclusion; Water and/or any cleansing product, applied on the whole body within 4 hours before the inclusion visit. If there is no studied area on the face, the subject is allowed to do a light face wash without time restriction (especially in the morning of the visit); Subject who plans to modify his/her usual moisturizer (allowed outside studied areas) and/or care habits during the study; Treatment of the mother if the subject of group 1 and 2 is breastfed:.