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
- 1
- 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
研究组 & 干预措施
acneic participants group
subjects with mild to moderate facial and truncal acne
干预措施: acneic participants group (Other)
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)