Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- wound healing assessment by the Investigator (number of days for complete re-epithelialization)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •phototype II and III on the Fitzpatrick scale
- •subjects with normal clinical examination and medical history compatible with the study
排除标准
- •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
结局指标
主要结局
wound healing assessment by the Investigator (number of days for complete re-epithelialization)
时间窗: 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).
次要结局
- wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)(from baseline to Day19)