NCT04709289已完成不适用
Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne
Shanghai Dermatology Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The clearance rate of lesions
研究概览
简要总结
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
详细描述
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Evaluator assesses photographs without prior knowledge of intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
- •(2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
- •(3) Patients who read the instructions and were willing to follow the program requirements.
排除标准
- •(1) Patients who had a history of photosensitive diseases;
- •(2) Patients who had Modified-PDT;
- •(3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
- •(4) Female patients who were pregnant or lactating.
结局指标
主要结局
The clearance rate of lesions
时间窗: 1 week after treatment
The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome
次要结局
- Assessment of adverse effects(up to 7 days after treatment.)
研究者
Xiuli Wang
Director, Clinical Professor
Shanghai Dermatology Hospital
研究点 (1)
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