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 | Terminated

• 1 other identifier: RV3895A20210368
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (16)

• Physical aspect of scar(s) compared to normal skin by the investigator

  The investigator assessed the physical appearance of the studied scar(s) in comparison to normal skin using the "POSAS Observer Scale" (Patient and Observer Scar Assessment Scale)

  Day 1, Day 22, Day 85, and Day 169

• Physical and functional aspect of scar(s) by the subject

  Subjects who were of age to complete the assessment evaluated the physical appearance in comparison to normal skin and the functional appearance of the studied scar(s) using the "POSAS Patient Scale"

  Day 1, Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit4

• Soothing effect

  The subject/parent(s) or legal guardian(s) evaluated the soothing effect using a Numerical Rating Scale (NRS) to assess discomfort over the past 3 days (except for the evaluation at Day 1 after application) from 0 (no discomfort) to 10 (severe discomfort)

  at Day 1 (before and after product application), Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit 4.

• Inflammatory aspect of scar

  The investigator evaluated the inflammatory aspect of the scar using the vitropression test

  at Day 1, Day 22, Day 85, and Day 169

• Evolution of scar aspect compared to Day 1

  The investigator assessed the evolution of the scar's appearance compared to D1 based on all parameters evaluated in the study using a dynamic Investigator's Global Assessment (IGA) scale ranging from -1 (worsening), 0 (no change), 1 (slight improvement), 2 (clear improvement), 3 (very clear improvement)

  at Day 22, Day 85, and Day 169

• Overall satisfaction with Test product (Investigator's assessment)

  The investigator assessed overall satisfaction with the product's impact on scar appearance based on usual practice and study parameters using an NRS from 0 (not at all satisfied) to 10 (very satisfied)

  at Day 22, Day 85, and Day 169

• Overall satisfaction with Test product (Subject/Parent/Guardian assessment)

  The subject/parent(s) or legal guardian(s) assessed overall satisfaction with the product's impact on scar appearance using an NRS from 0 (not at all satisfied) to 10 (very satisfied)

  at Day 22, Day 85, and Day 169

• Erythema quantification

  Erythema was quantified using chromametry through spectrocolorimetric parameters

  at Day 1, Day 22, Day 85, and Day 169

• Dermatology Life Quality Index (DLQI)

  Quality of life was assessed by subjects of appropriate age using the Dermatology Life Quality Index (DLQI) questionnaire

  at Day 1, Day 22, Day 85, and Day 169 and monthly at home between Visit 2 and Visit 4

• Specific impact of burns on quality of life

  For subgroup 1a (Burns) only : evaluated by subjects using the "body image" and "heat sensitivity" subdomains of the Burn Specific Health Scale-Brief (BSHS-B)

  at Day 1, Day 22, Day 85, and Day 169

• Visual aspect of the scar through illustrative photographs

  at Day 1, Day 22, Day 85, and Day 169.

• The quantity of product used calculated by weighing the tubes

  Between Day 1 and Day 169

• Subjective cosmetic acceptability of the product

  The subjective cosmetic acceptability of the product was evaluated by the subject/parent(s) or legal guardian(s) using a questionnaire

  at Day 22, Day 85, and Day 169

• Recording of adverse events

  At each visit, the occurrence of adverse events since the last visit was determined based on spontaneous reports from the subject/parent(s) or legal guardian(s), non-subjective questioning, and clinical evaluations performed by the investigator. All adverse events were recorded in the Case Report Form (CRF)

  at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169

• Overall tolerance assessed by the investigator

  Overall tolerance was assessed by the investigator considering all individual adverse events and their characteristics, as well as past experience with similar products, using a 5-point scale (Excellent, Very Good, Good, Moderate, Poor)

  at Day 22, Day 85, and Day 169

• Compliance

  The subject was to record in their subject diary the applications of the study product, as well as any omissions and changes in frequency

  Duration of the study, from Day 1 to Day 169

Study Arms (3)

Group 1A

Adults with post-burn scar(s)

Other: Product gel RV3895A

Group 1C

Adults with post-suture scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches).

Other: Product gel RV3895A

Group 2A

Children/adolescents with post-burn scar(s).

Other: Product gel RV3895A

Interventions

Product gel RV3895A OTHER

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.

Group 1A; Group 1C; Group 2A

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects were recruited from their usual consultations and/or from the centre's registry. If necessary, advertisements were used. Subjects corresponding to the eligibility criteria could receive a telephone call, letter or email offering them to take part in this clinical study.

You may qualify if:

• Male or female
• For group 1: subjects aged between 18 to 65 included
• For group 2: subjects aged between 2 to 17 years included
• Subject with superficial scar(s):
• Red and re-epidermised
• Less than 6 months old
• For subgroups 1A and 2A: Located on the body and/or face
• For sub-group 1C: Located on the upper limbs and/or neck and/or face
• For group 1A: spread over an area less than or equal to 30% of the body surface area
• For group 1C: spread over an area less than or equal to 15% of the body surface area
• For group 2: spread over an area less than or equal to 10% of the body surface area
• For sub-groups 1A and 2A: deep 2nd degree burns, whether grafted or not and/or in the 3rd degree graft(s) with limited cutaneous involvement and preservation of underlying structures
• For sub-group 1C: post-surgical suture requiring stitches to be inserted and removed if applicable (case of non-absorbable stitches)
• Subject with abundant hairiness on the instrumental measurement area
• Subject with a known history of scarring problems such as keloid scars

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Clinique de Rééducation et de Réadaptation Fonctionnelle du Docteur Jean Ster

Lamalou-les-Bains, 34240, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 13, 2025
• Study Start: November 23, 2021
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

FR (1)