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).
Study Type
OBSERVATIONAL
Enrollment
21
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).
Skin Research Centre
Toulouse, Haute-Garonne, France
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©
Time frame: 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.
Skin microbiota diversity from swab samples.
Microbiota composition is analyzed by 16S and ITS1sequencing.
Time frame: 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.
Shannon, Chao1 and Observed diversity indexes for bacteria and fungi are calculated with the number of identified sequences obtained with 16S and ITS1sequencing.
Time frame: 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
Time frame: 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.
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