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

NCT07014007 | Recruiting

• 1 other identifier: RV44221B20240736
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Atopic Dermatitis

Keywords

Atopic Dermatitis; Eczema; Flare; Inflammatory skin disease; Altered skin barrier; Dryness; Itching; Redness; Stinging; Burning sensation

Outcome Measures

Primary Outcomes (1)

• Local tolerance of the product RV4421B-EV0407 on studied areas

  The results of the local tolerance will take into account the clinical signs observed by the investigators and the signs reported by the subject and/or the subjects' parent(s) or guardian(s), based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)

  Day 85

Secondary Outcomes (11)

• Local tolerance of the product RV4421B-EV0407 on studied areas at several timepoints

  Day 1, 10 to 30 minutes after the first application, Day 29 & Day 57

• Recording of adverse events

  From Day 1 to Day 85

• Local-SCORAD (SCORing Atopic Dermatitis)

  Day 1, Day 29, Day 57 & Day 85

• SCORAD (SCORing Atopic Dermatitis)

  Day 1, Day 29, Day 57 & Day 85

• IGA (Investigator's Global Assessment)

  Day 1, Day 29, Day 57 & Day 85

Study Arms (3)

Infant group

EXPERIMENTAL

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.

Device: RV4421B- EV0407

Children group

EXPERIMENTAL

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.

Device: RV4421B- EV0407

Teenagers & adults group

EXPERIMENTAL

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.

Device: RV4421B- EV0407

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.

Children group; Infant group; Teenagers & adults group

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \*The investigator will be authorized to adjust the treatment during the study.

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Insight Research Ltd

Quatre Bornes, Mauritius, 742CU001, Mauritius

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Pruritus; Erythema; Paresthesia

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

Adeline Bacquey

CONTACT

+33534506533; adeline.bacquey@pierre-fabre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 10, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

MA (1)