A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of ACYC and ACYC Vehicle Gel in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 498
- 主要终点
- Absolute Change in Inflammatory Lesion Count
研究概览
简要总结
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
详细描述
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 12 and 40 (inclusive)
- •Written and verbal informed consent must be obtained.
- •Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
- •Subject must have moderate to severe acne at the baseline visit
- •Women of childbearing potential must be willing to practice effective contraception for the duration of the study
排除标准
- •Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
- •Dermatological conditions on the face that could interfere with clinical evaluations
研究组 & 干预措施
ACYC
ACYC active, topically applied to the face for 12 weeks
干预措施: ACYC (Drug)
ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
干预措施: ACYC vehicle (Drug)
结局指标
主要结局
Absolute Change in Inflammatory Lesion Count
时间窗: Baseline and 12 Weeks
Absolute Change in Non-inflammatory Lesion Count
时间窗: Baseline and 12 Weeks
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
时间窗: Baseline and 12 Weeks
Percent of Subjects Who Have a Least a 2 Grade Reduction
时间窗: Baseline and 12 Weeks
次要结局
未报告次要终点