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

NCT ID: NCT07020507

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2023-10-03

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1A

Adults with post-burn scar(s)

Product gel RV3895A

Intervention Type: 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 1C

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

Product gel RV3895A

Intervention Type: 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 2A

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

Product gel RV3895A

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• 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.).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de Rééducation et de Réadaptation Fonctionnelle du Docteur Jean Ster

Lamalou-les-Bains, , France

Countries

France

Other Identifiers

RV3895A20210368

Identifier Type: -

Identifier Source: org_study_id