Exploratory Study to Evaluate the Efficacy of the Cosmeti... | NCT07020507

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1A	Adults with post-burn scar(s)	Other: Product gel RV3895A
Group 1C	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
Group 2A	Children/adolescents with post-burn scar(s).	Other: Product gel RV3895A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Product gel RV3895A	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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"	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)	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	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)	at Day 22, Day 85, and Day 169
Overall satisfaction with Test product (Investigator's assessment)

Eligibility Module

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.).