Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- efficacy on total acne lesion count on face and trunk
研究概览
简要总结
This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.
详细描述
The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.
Statistical methodology:
Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median & measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.
Significance level:
The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •phototype I to VI
- •mild to moderate acne on the face and trunk
排除标准
- •cutaneous pathology on the studied zone other than acne
- •topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products
结局指标
主要结局
efficacy on total acne lesion count on face and trunk
时间窗: from baseline to Day168
The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.
次要结局
- Evaluation of the degree of severity of acne on the trunk(from baseline to Day168)
- Evaluation of the degree of severity of acne on the face(from baseline to Day168)