Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing

Cosmetique Active International25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Wound Heal

Interventions

superficial CO2 laser resurfacingOTHER

Application of the tested product and comparators on the laser treated side of the back

Laser untreated sideOTHER

Application of the tested product and comparators on the laser untreated (control) side of the back

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * phototype II and III on the Fitzpatrick scale * subjects with normal clinical examination and medical history compatible with the study Exclusion Criteria: * subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology * subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study * subject who has taken systemic treatment for more than 5 days in the month prior to inclusion

Locations (1)

CPCAD

Nice, France

Outcomes

Primary Outcomes

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).

Time frame: from baseline to Day19

Secondary Outcomes

wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)

Time frame: from baseline to Day19

Data from ClinicalTrials.gov

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