Stopped: Due to recruitment difficulties, the number of subjects included (n=35) was lower than expected (n=60).
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 )
Age range
2 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Physical aspect of scar(s) compared to normal skin by the investigator
Timeframe: Day 1, Day 22, Day 85, and Day 169
Physical and functional aspect of scar(s) by the subject
Timeframe: Day 1, Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit4
Soothing effect
Timeframe: 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
Timeframe: at Day 1, Day 22, Day 85, and Day 169
Evolution of scar aspect compared to Day 1
Timeframe: at Day 22, Day 85, and Day 169
Overall satisfaction with Test product (Investigator's assessment)
Timeframe: at Day 22, Day 85, and Day 169
Overall satisfaction with Test product (Subject/Parent/Guardian assessment)
Timeframe: at Day 22, Day 85, and Day 169
Erythema quantification
Timeframe: at Day 1, Day 22, Day 85, and Day 169
Dermatology Life Quality Index (DLQI)
Timeframe: 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
Timeframe: at Day 1, Day 22, Day 85, and Day 169
Visual aspect of the scar through illustrative photographs
Timeframe: at Day 1, Day 22, Day 85, and Day 169.
The quantity of product used calculated by weighing the tubes
Timeframe: Between Day 1 and Day 169
Subjective cosmetic acceptability of the product
Timeframe: at Day 22, Day 85, and Day 169
Recording of adverse events
Timeframe: at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169
Overall tolerance assessed by the investigator
Timeframe: at Day 22, Day 85, and Day 169
Compliance
Timeframe: Duration of the study, from Day 1 to Day 169