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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.
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 4.0.2. 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 0.05 and assuming a common standard deviation of ±2.7 days. Twenty-five (25) subjects will be included in the study to take into account possible dropouts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| superficial CO2 laser resurfacing | Experimental | The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. |
|
| Laser untreated side | Active Comparator | The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| superficial CO2 laser resurfacing | Other | Application of the tested product and comparators on the laser treated side of the back |
|
| Measure | Description | Time Frame |
|---|---|---|
| wound healing assessment by the Investigator (number of days for complete re-epithelialization) | assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: <25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: >75% of the lesion area); 5 (Complete healing). | from baseline to Day19 |
| Measure | Description | Time Frame |
|---|---|---|
| wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization) | assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: <25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: >75% of the lesion area); 5 (Complete healing). | from baseline to Day19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel | Centre de Pharmacologie Clinique Applique a la Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD | Nice | France |
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| Laser untreated side | Other | Application of the tested product and comparators on the laser untreated (control) side of the back |
|