Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- evaluation of the effect on the recovery of irritated skin lesions
研究概览
简要总结
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).
详细描述
Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
- Number of values
- Mean
- Median
- Standard deviation (SD)
- Minimum value
- Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ...
- •localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
- •subjects having a feeling of discomfort at the site of the lesion.
排除标准
- •cutaneous pathology on the studied zone (other than the required irritations)
- •use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation);
- •subject with healing disorder (keloid, hypertrophic)
- •subject with Type 1 diabetic
- •subject under chemotherapy and radiotherapy
- •subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis
结局指标
主要结局
evaluation of the effect on the recovery of irritated skin lesions
时间窗: from baseline to Day21
the investigator evaluates the improvement of the tested product using the IGA score on a 6-point scale (from -1: aggravation to 4: complete recovery)
次要结局
- evaluation of the local signs of irritated area(from baseline to Day21)
- evaluation of the skin sensitivity(from baseline to Day21)
- evaluation of the global tolerance by the patient(from baseline to Day21)
- evaluation of the anti-irritating effect(from baseline to Day21)
- evaluation of the global tolerance by the investigator(from baseline to Day21)
- evaluation of post-recovery marks(Day21)
- evaluation of the global effect by the investigator(Day21)
- evaluation of the global effect by the patient(Day21)