NCT01180543已完成2 期
Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Severity Score of lesion
研究概览
简要总结
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
详细描述
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acne Vulgaris
- •Over 18 years
- •Signing informed consent
排除标准
- •Active treatment of acne
- •Change in hormonal therapy
- •Antibiotic treatment in a week prior to the experiment
- •Sensitive skin
- •Pregnancy
研究组 & 干预措施
Active Comparator: Oplon Active Patch
Active Comparator
干预措施: Oplon Active Patch (Device)
Placebo Comparator: Placebo patch
Placebo Comparator
干预措施: Placebo Patch (Device)
结局指标
主要结局
Severity Score of lesion
时间窗: Severity Score of lesion [Time Frame: 24 hours following patch removal]
Lesions were ranked by investigator according to severity whereas: 0-clear, 1-mild, 2-moderate, 3-sever
次要结局
- Severity Score of lesion(Severity Score of lesion [Time Frame: 12 hours with the patch])
研究者
研究点 (2)
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