NCT02313467已完成不适用
Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percent change of inflammatory acne lesions compared with baseline
研究概览
简要总结
In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.
排除标准
- •known pregnancy
- •lactation
- •any medical illness that might influence the results of the study
- •a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
- •use of topical acne medication within 4 weeks of study enrollment.
研究组 & 干预措施
1.5% Butenyl ALA
Active Comparator
Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face
干预措施: Topical application of 1.5% Butenyl ALA (Drug)
Control
Sham Comparator
Topical application of sham control per every other day around acne lesions in the face
干预措施: Topical application of sham control (Drug)
结局指标
主要结局
Percent change of inflammatory acne lesions compared with baseline
时间窗: 12 week
次要结局
- Percent change of non-inflammatory acne lesions compared with baseline(12 week)
- Percent change of overall severity of acne lesions compared with baseline(12 week)
研究者
Dae Hun Suh
Professor
Seoul National University Hospital
研究点 (1)
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