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

Pierre Fabre

Status

Terminated

Conditions

Post-surgical-stitches Scars

Post-burn Scars

Skin Scars

Treatments

Other: Product gel RV3895A

Study type

Observational

Funder types

Industry

Identifiers

NCT07020507

RV3895A20210368

Details and patient eligibility

About

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 )

Enrollment

35 patients

Sex

All

Ages

2 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.).