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

Overview

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)

Interventions

• Device RV4421B- EV0407
  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.

Primary outcome measures

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

Secondary outcome measures (11)

• Local tolerance of the product RV4421B-EV0407 on studied areas at several timepoints [Time frame: Day 1, 10 to 30 minutes after the first application, Day 29 & Day 57]
• Recording of adverse events [Time frame: From Day 1 to Day 85]
• Local-SCORAD (SCORing Atopic Dermatitis) [Time frame: Day 1, Day 29, Day 57 & Day 85]
• SCORAD (SCORing Atopic Dermatitis) [Time frame: Day 1, Day 29, Day 57 & Day 85]
• IGA (Investigator's Global Assessment) [Time frame: Day 1, Day 29, Day 57 & Day 85]
• PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) [Time frame: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 1 to Day 85]
• SGA (Subject's Global Assessment) [Time frame: Every 2 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 15 to Day 85]
• Subject quality of life DLQI for subjects from 16 years [Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85]
• Subject quality of life CDLQI for subjects from 4 years to 15 years included [Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85]
• Subject quality of life IDQOL for subjects from 3 months to 3 years included [Time frame: Every 4 weeks ± 2 days (or during the visit at site for sequences close to visit at site) from Day 29 to Day 85]
• Subject's satisfaction questionnaire [Time frame: at Day 1 (10 to 30 minutes after the 1st product application), within 2 days before Day 29 or at Day 29 (± 3 days), within 2 days before Day 85 or at Day 85 (± 3 days)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Mauritius · 1 center

• Insight Research Ltd — Quatre Bornes

Identifiers

NCT: NCT07014007 · RV44221B20240736

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗