Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467032
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
Official Title:
Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This monocentric double-blinded randomized with intra-individual comparisons study is an interventional cosmetic study
The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area
The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area
Detailed Description:
This clinical trial is conducted in accordance with the protocol the Helsinki declaration 1964 and subsequent amendments and the International Council on Harmonisation ICH Good Clinical Practice GCP and in compliance with applicable regulatory requirements
Statistical method analysis will be performed using R software version 402 or higher All statistical tests will be two-sided and at the 5 level of significance Normality tests will be at the 1 level of significance Shapiro-Wilk All efficacy evaluation will be done on the Per Protocol Set
The categorical variables are summarized by frequency and percentage for each response category N The continuous variables are summarized using means medians minimum maximum and standard deviations for the data collected at each visit
Sample size determination A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91 at a risk alpha of 005 and assuming a common standard deviation of 27 days Twenty-five 25 subjects will be included in the study to take into account possible dropouts
Statistical method analysis will be performed using R software version 402 or higher All statistical tests will be two-sided and at the 5 level of significance Normality tests will be at the 1 level of significance Shapiro-Wilk All efficacy evaluation will be done on the Per Protocol Set
The categorical variables are summarized by frequency and percentage for each response category N The continuous variables are summarized using means medians minimum maximum and standard deviations for the data collected at each visit
Sample size determination A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91 at a risk alpha of 005 and assuming a common standard deviation of 27 days Twenty-five 25 subjects will be included in the study to take into account possible dropouts
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