Healthy Clinical Trial
Official title:
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
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.
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). ;
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