NCT06387277

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

Assessment of the Impact of Skin Microbiota on Wound Healing Process Using an Epidermally Ablated Skin Model of Erbium YAG Laser by Comparing Areas Treated With RV1551P GB3224 With Untreated: Exploratory Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a monocentric, open-label, intra-individual, controlled and randomized study conducted in 21 healthy adults. A comparison is done between areas treated with the product RV1551P GB3224 and untreated areas (randomized arms). The swab samples are performed on 4 study areas: 2 areas on the volar aspect of each forearm identified Z1, Z2, Z3 and Z4. Two areas are epidermally ablated with an erbium YAG laser at Visit 1 (D1) with a surface around 6cm² (Z1 and Z3): one area is treated with the product RV1551P GB3224 and the other one is untreated. On these areas, four swab samples are performed: at Day 1 before and after the laser act at the inclusion visit (V1-D1), at Day 5 (V4-D5), at visit corresponding to complete wound healing (re-epithelialization time) and at the end of study (V9-D19). Two healthy areas (Z2 and Z4), with a surface around 6cm², are identified on each forearm. One of these areas is treated with the product RV1551P GB3224. On these areas, two swab samples are performed: at the inclusion visit (V1-D1), and at the end of study (V9-D19).

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	RV1551P GB3224	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).

Timeline

• Start date: 2022-09-19
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2024-04-29
• Last updated: 2024-04-29

Locations

1 site across 1 country: France