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

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Other: superficial CO2 laser resurfacing; Other: Laser untreated side

• Registration Number: NCT06467032
• Lead Sponsor: Cosmetique Active International

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.

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 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 Timeline

• Study Start: 2023-01-16
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superficial CO2 laser resurfacing	superficial CO2 laser resurfacing	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	Laser untreated side	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.

Primary Outcome Measures

Name	Time	Method
wound healing assessment by the Investigator (number of days for complete re-epithelialization)	from baseline to Day19	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).

Secondary Outcome Measures

Name	Time	Method
wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)	from baseline to Day19	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).

Trial Locations

Locations (1)

CPCAD; 🇫🇷 Nice, France