Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387277
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-04-09
Brief Title:
Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Pierre Fabre Dermo Cosmetique
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None