RV4421B cream for tolerance and effectiveness in atopic dermatitis over 12 weeks
Official title: 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
Run by Pierre Fabre Dermo Cosmetique · NCT07014007 · Data updated 2026-11-12
This 12-week open-label test will try the marketed cream RV4421B-EV0407, alone or with topical steroid treatment, in infants, children, teens, and adults with mild-to-moderate atopic dermatitis to see if it is safe and improves their skin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months and up |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Pierre Fabre Dermo Cosmetique Industry-sponsored |
| Locations | 1 site (Quatre Bornes, Mauritius) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07014007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 3 months and older with mild-to-moderate atopic dermatitis affecting up to 30% of the body surface and who can attend scheduled visits in Mauritius, including those already using topical corticosteroids.
✕Probably not a fit
Patients with severe atopic dermatitis, more than 30% body surface involvement, or those requiring systemic immunosuppressive therapy are unlikely to benefit from this study intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, 12-week interventional study of RV4421B-EV0407 applied alone or alongside topical corticosteroids in ethnically diverse participants including infants, children, adolescents, and adults with mild-to-moderate atopic dermatitis. Participants with affected skin up to 30% of body surface area will be followed through five scheduled contacts (one phone visit and four in-person visits). The protocol allows topical corticosteroid use per guidelines and investigator discretion, with adjustments permitted during the study. Safety (tolerance) and measures of skin signs and symptoms will be collected to characterize the product’s performance across age groups and skin phototypes.
Why it matters
Potential benefit: If successful, the cream could improve eczema symptoms and skin barrier function and potentially reduce the need for higher-potency topical steroids in people with mild-to-moderate atopic dermatitis.
How similar studies have gone: Barrier-repair emollients and device-class topical creams have shown symptomatic benefit in other eczema studies, though published randomized data specific to this RV4421B formulation are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: Criteria related to the skin condition or the disease: * Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 \& 2) * 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: * 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 * 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: * 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
Where it's running
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Insight Research Ltd
Quatre Bornes, Mauritius, Mauritius Recruiting
Study contacts
- Study coordinator: Adeline Bacquey
- Email: adeline.bacquey@pierre-fabre.com
- Phone: +33534506533
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.