An observational study in Skin Scars, Post-burn Scars and Post-surgical-stitches Scars, sponsored by Pierre Fabre Dermo Cosmetique. Terminated at 1 site in France. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Pierre Fabre Dermo Cosmetique · Observational
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:
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 )
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 35 is close to the median of 38 across 34 observational studies indexed under Cicatrix.
Browse Cicatrix studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
INCLUSION CRITERIA :
Subject with superficial scar(s):
NON-INCLUSION CRITERIA:
Adults with post-burn scar(s)
Other: Product gel RV3895A
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
Children/adolescents with post-burn scar(s).
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.
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)
Time frame: 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"
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: at Day 22, Day 85, and Day 169
Erythema quantification
Erythema was quantified using chromametry through spectrocolorimetric parameters
Time frame: 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
Time frame: 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)
Time frame: at Day 1, Day 22, Day 85, and Day 169
Visual aspect of the scar through illustrative photographs
Time frame: at Day 1, Day 22, Day 85, and Day 169.
The quantity of product used calculated by weighing the tubes
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Duration of the study, from Day 1 to Day 169
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique