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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06467032
• Other study ID #: LRP21007 Cicaplast
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: April 21, 2023

Study information

• Verified date: June 2024
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

Other:
• superficial CO2 laser resurfacing
Application of the tested product and comparators on the laser treated side of the back
• Laser untreated side
Application of the tested product and comparators on the laser untreated (control) side of the back

Locations

Country	Name	City	State
France	CPCAD	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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