NCT07020507

Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance and quality of life.The aim of this study is to evaluate the efficacy of the cosmetic product RV3895A - RY1774 on re-epidermised scars of the face and body following burns and surgical stitches in adults, adolescents and children over a 6-month follow-up period. Patients are divided into 2 groups: * Group 1: adults with: * Subgroup 1A: adults with post-burn scar(s) * Subgroup 1C: adults with post-surgical scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches). * Group 2: children and/or adolescents including children aged 2 to 7 years inclusive with: * Subgroup 2A: children/adolescents with post-burn scar(s) The study consists of 4 visits: Visit 1: Inclusion (Day 1), Visit 2: Intermediate visit (Day 22), Visit 3: Intermediate visit (Day 85), Visit 4: End-of-study visit (planned or anticipated) (Day 169 )

Conditions

• Skin Scars
• Post-burn Scars
• Post-surgical-stitches Scars

Interventions

Type	Name	Description
OTHER	Product gel RV3895A	The product is applied twice a day to the scar(s) under study, avoiding all contact with natural orifices (and avoiding ingestion by children in the case of application to the hands in particular). The product is applied using a specific massage technique developed for the product and which is explained by the investigator at visit 1. The product is applied in sufficient quantity to cover the application area.

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: France