Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women

NCT06387277 | Completed

• 1 other identifier: RV1551P20220376
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser.

Conditions

Healthy

Keywords

Female; 20 to 45 years old; re-epithelialization; microbiota; metabolomic

Outcome Measures

Primary Outcomes (1)

• Time to re-epithelialization as assessed by in vivo examination by the investigator and standardized photographs taken with a C Cube Camera®

  The wound disappearance is assessed by the investigator from in vivo examination and from standardized photographs of the study areas taken at each visit with a C Cube Camera®. Illustrative photographs will be collected by NomadCam©

  Change from baseline to 10 minutes after the YAG laser act, before the application of the product. During the following visits (Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 19), the photographs will be taken before the product is applied.

Secondary Outcomes (3)

• Skin microbiota diversity from swab samples.

  Change from baseline to 10 minutes after the YAG laser act, Day 5, re-epithelialization time and Day 19, before the application of the product.

• Skin microbiota composition from swab samples.

  Change from baseline to 10 minutes after the YAG laser act, Day 5, re-epithelialization time and Day 19, before the application of the product.

• Metabolomic analysis from swab samples

  Change from baseline to 10 minutes after the YAG laser act, Day 5, re-epithelialization time and Day 19, before the application of the product.

Study Arms (1)

Arms of healthy female from 20 to 45 years old

It is a randomized intra-individual comparative study where two areas of the skin are ablated using an erbium YAG laser at Visit 1, with a surface area of approximately 6cm² (Z1 and Z3). Additionally, two healthy areas (Z2 and Z4), with a similar surface area, are identified on each forearm. The study involves comparing the areas treated with the product RV1551P GB3224 to the untreated areas (randomized arms).

Other: RV1551P GB3224

Interventions

RV1551P GB3224 OTHER

RV1551P GB3224 Approximately 2 mg/cm² of product is applied to the Z1 or Z3 study areas (randomization). From D1 to D2, a single product application is done at the study center by the subject in the presence of the clinical research technician (CRT) after epidermal ablation with an erbium YAG laser. After application, a dressing is placed on the measurement area and removed the following day at the center on D2 and D3 by the CRT before measurements. From D3 to D18, two product applications are done with a minimum 4-hour interval: * On visit days (D3, D5, D8, D10, D12, D15): an application is done at the study center by the subject in the presence of the CRT after measurements. A second application is done at home in the evening. * On non-visit days (D4, D6, D7, D9, D11, D13, D14, D16, D17, D18): the subject applies 2 product applications at home (morning and evening). Subjects receive the product at the end of visit 3 and return it at the last visit (visit 9).

Arms of healthy female from 20 to 45 years old

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects have been recruited from the panel of the centre. An investigator made a dermatological examination of the subjects before inscription in the panel. Data from this clinical examination, stored in the computer database with the consent of the subjects, can ensure the recruitment; computer software being questioned based on the eligibility criteria of the study.

You may qualify if:

• Criteria related to the population:
• Male or female, from 20 to 45 years old included.
• Phototype I, II or III according to the Fitzpatrick classification.
• Subject smoking ≤ 10 cigarettes / day containing nicotine, paper and/or electronic cigarette equivalent.
• Subject agreeing not to expose his forearms to UV (natural or artificial) throughout the duration of the study and up to 3 months after the end of participation in the study.
• If the subject is a woman of childbearing age:
• ii. Subject agreeing to continue using it during all the study and up to 5 days after the last products application, in order to avoid pregnancy during exposure to the study products.
• Absence from participation in a clinical research protocol.
• Signature of the informed consent form.
• Affiliation to social security scheme or beneficiary of such a scheme.
• Criteria related to treatment:
• Subject protected by a tetanus vaccination according to the vaccination schedule established by the Public Health Agency.

You may not qualify if:

• Criteria related to the population:
• Pregnancy or breastfeeding ongoing or planned during the study.
• Subject deprived of freedom through a legal or administrative decision, or in care or under legal guardianship.
• Subject unable to comply with the requirements of the protocol according to the opinion of the investigator.
• Physical or linguistic impairment for signing the informed consent form.
• Current participation planned participation or participation in previous weeks or months in another clinical study that may interfere with the study according to the opinion of the investigator.
• Subject who has participated twice in a clinical study using the Er YAG laser on the forearms.
• Criteria related to diseases and general health:
• Subject with known immunodeficiency.
• Subject with known acquired immunodeficiency syndrome.
• Subject with known infectious hepatitis or a known history of hepatitis B or C.
• Subject with a known history of allergy or contact dermatitis induced in particular by the latex, the plaster, the local anesthetic, the local antiseptic or one of the components of the study products.
• Subject with a recognized addiction to alcoholism or drug.
• Subject having already presented cicatrization disorders.
• Subject presenting pathology of cicatrization or pathology with consequences on cicatrization such as diabetes.

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Centre

Toulouse, Haute-Garonne, 31300, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Swab samples on the skin surface to access skin microbiota and metabolites produced by the skin and microbiota.

Study Officials

• Jennifer THEUNIS, MD

  SKIN RESEARCH CENTRE - Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 29, 2024
• Study Start: September 19, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)