Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Skin Scars
Post-burn Scars
Post-surgical-stitches Scars
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 )


Eligibility criteria: INCLUSION CRITERIA :

* 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)

NON-INCLUSION CRITERIA:

* Subject with abundant hairiness on the instrumental measurement area
* Subject with a known history of scarring problems such as keloid scars
* Subject with superinfected scar(s)
* Subject with non-re-epidermised scar(s)
* Subject with contraindications to scar massage according to investigator assessment (dermatological conditions, treatment, pathologies, etc.) apart from a stage of scarring or a type of scar that does not allow scar massage (e.g. inflammatory scar).
* Subject with another dermatological condition (including pityriasis versicolor, severe pigmentation disorders (vitiligo, melasma, multiple lentigines, numerous and/or congenital nevi in particular if extensive)) or characteristics (e.g. tattoo) on the studied scar(s), liable to interfere with the study evaluations, or considered hazardous for the subject or incompatible with the study requirements, in the opinion of the investigator
* Subject with a pathology that may interfere with the healing stages (such as vascular pathologies, diabetes, chronic smoking associated with vascular complications...)
* Systemic treatments derived from vitamin A (retinoids, etc.) taken within the 2 months before the inclusion visit or planned during the study
* Systemic treatment with corticosteroids and/or immunosuppressants taken within the 4 weeks before the inclusion visit or planned during the study
* Surgery (other than that which caused the scar(s)) or chemical or significantly invasive dermatological treatment on the studied scar(s) liable to interfere, according to investigator assessment, with the study results within the previous weeks before the inclusion visit or planned during the study
* Systemic or topical treatments on the studied scar(s) having an influence on pruritus (benzodiazepines, antihistamines...) established or modified within the weeks before the inclusion visit or planned to be established or modified during the study and considered as not stabilised according to investigator assessment
* Topical corticosteroid and/or immunosuppressants treatments applied on the studied scar(s) within 2 weeks before the inclusion visit or planned during the study
* Silicone-based scar treatment/product(s) applied within the wound healing phase to the studied scar(s)
* Any other scar care product(s) (emollient, etc.) applied on the studied scar(s) within the week before the inclusion visit\*
* Water applied on the studied scar(s) within 2 hours before the inclusion \* Other medicinal or physical treatments for the scar(s) are authorised (clothing/compressive dressings, massages, stabilised topical antihistamines, thermal water, etc.).

Primary outcomes:
measure: Physical aspect of scar(s) compared to normal skin by the investigator
timeFrame: Day 1, Day 22, Day 85, and Day 169
measure: 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
measure: 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.
measure: Inflammatory aspect of scar
timeFrame: at Day 1, Day 22, Day 85, and Day 169
measure: Evolution of scar aspect compared to Day 1
timeFrame: at Day 22, Day 85, and Day 169
measure: Overall satisfaction with Test product (Investigator's assessment)
timeFrame: at Day 22, Day 85, and Day 169
measure: Overall satisfaction with Test product (Subject/Parent/Guardian assessment)
timeFrame: at Day 22, Day 85, and Day 169
measure: Erythema quantification
timeFrame: at Day 1, Day 22, Day 85, and Day 169
measure: 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
measure: Specific impact of burns on quality of life
timeFrame: at Day 1, Day 22, Day 85, and Day 169
measure: Visual aspect of the scar through illustrative photographs
timeFrame: at Day 1, Day 22, Day 85, and Day 169.
measure: The quantity of product used calculated by weighing the tubes
timeFrame: Between Day 1 and Day 169
measure: Subjective cosmetic acceptability of the product
timeFrame: at Day 22, Day 85, and Day 169
measure: Recording of adverse events
timeFrame: at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169
measure: Overall tolerance assessed by the investigator
timeFrame: at Day 22, Day 85, and Day 169
measure: Compliance
timeFrame: Duration of the study, from Day 1 to Day 169
Secondary outcomes:
Other outcomes:
Locations:
city: Lamalou les Bains
country: France
facility: Clinique de Rééducation et de Réadaptation Fonctionnelle du Docteur Jean Ster
Study officials:
References: