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

Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal
• Intervention / Treatment: Other: superficial CO2 laser resurfacing; Other: Laser untreated side

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CPCAD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: superficial CO2 laser resurfacing; Application of the tested product and comparators on the laser treated side of the back
Active Comparator: 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.	Other: Laser untreated side; Application of the tested product and comparators on the laser untreated (control) side of the back

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Catherine Queille-Roussel, Centre de Pharmacologie Clinique Applique a la Dermatologie

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: re-epithelialization; superficial CO2 laser resurfacing; Cicaplast Baume B5
• Other Study ID Numbers: LRP21007 Cicaplast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No