Clinical trial NCT06467032: Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
Official title: Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: re-epithelialization
superficial CO2 laser resurfacing
Cicaplast Baume B5
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-06-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound healing assessment by the Investigator (number of days for complete re-epithelialization)
timeFrame: from baseline to Day19
Secondary outcomes:
measure: wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)
timeFrame: from baseline to Day19
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD
Study officials:
affiliation: Centre de Pharmacologie Clinique Applique a la Dermatologie
name: Catherine Queille-Roussel
role: PRINCIPAL_INVESTIGATOR
References: