DRKS00025008已完成未知
Evaluation of the safety and efficacy of the BioWeld1 system in the treatment of acne vulgaris - CLP213
IonMed Ltd.0 个研究点目标入组 34 人开始时间: 2021年4月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Inclusion criteria were age of at least 18 years, moderate papulopustular acne with lesions on both sides of the face, Investigator Global Assessment (IGA) scale score of 3 at baseline, a negative urine or serum pregnancy test in female subjects, the ability of the subject to comply with the procedures required and written informed consent. Only patients were enrolled who did not adequately respond to or did not tolerate standard acne treatments.
排除标准
- •Exclusion criteria were concomitant topical or systemic acne treatments or antibiotic treatments (topical acne treatment during four weeks preceding study treatment and systemic acne treatment during eight weeks preceding study treatment), planned topical or systemic acne treatments other than plasma in the next ten weeks, nodulocystic acne, suppression of the immune system, chronic malnutrition, diabetes, asthma, participation in other clinical trial, skin diseases that might interfere with the evaluation of study treatment, psychiatric disorders, prisoners, pregnancy, lactation, active implants such as pacemakers or pulse generators or implanted cardiac defibrillators, severe internal diseases, severe ocular diseases and severe skin diseases affecting the face.
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