Randomized Controlled Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The reduction rate of number of acne lesions
研究概览
简要总结
The purpose of the study is to testify the efficacy of treating moderate-to-severe acne vulgaris with Single Microneedle Radiofrequency, and provide evidence for the hypothesis that "whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris."
详细描述
The purpose of the study is to testify whether Single Microneedle Radiofrequency is effective for moderate-to-severe acne vulgaris, through treating moderate-to-severe acne vulgaris patient for 1 month, using photodynamic therapy as controlled group, and try to provide clinical evidence for the hypothesis that "whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris."
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
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent with the diagnostic criteria of moderate-to-severe acne vulgaris (IGA3-4) .
- •Age of a subject is older than 14 and is younger than 45.（including 14 and 45）.
- •Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial.
- •Informed consent is signed by a subject or his lineal relation.
排除标准
- •systemic acne treatment with oral isotretinoin within 6 months or oral antibiotics in the past 1 month;
- •history of facial procedures like dermabrasion, chemical, or laser peels;
- •history of photosensitive diseases, porphyria, or porphyrin sensitivity.
- •With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- •Pregnant women or women in lactation.
结局指标
主要结局
The reduction rate of number of acne lesions
时间窗: 16 weeks
Measure the reduction rate of number of acne lesions at 16 weeks after treatment compared with a baseline
次要结局
未报告次要终点