临床试验/NCT01293552

NCT01293552已完成2 期

Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

Anterios Inc.29 个研究点分布在 1 个国家目标入组 72 人开始时间: 2011年1月最近更新: 2013年7月4日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Anterios Inc.
入组人数: 72
试验地点: 29
主要终点: Efficacy will be assessed by lesion count.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•diagnosis of moderate to severe facial acne
•15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
•no presence of nodules
•female subjects must be not pregnant and non-lactating

排除标准

•presence of 1 or more nodules
•use of topical steroids on the face 4 weeks prior and during the study
•use of systemic corticosteroids 6 weeks prior and during the study
•topical or systemic acne treatment in the 4 weeks prior to Baseline

结局指标

主要结局

Efficacy will be assessed by lesion count.

时间窗: Week 4

inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)

次要结局

Change from Baseline in Investigator Global Assessment Score(Week 1, 2, 4, 8, and 12)
Change from Baseline in Lesion Count(Week 1, 2, 4, 8, 12)

研究者

发起方

申办方类型

Industry

责任方

Sponsor

研究点 (29)

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