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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

NCT07020507 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-10-03
Completion
2023-10-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020507 on ClinicalTrials.gov