An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Allergan
- 主要终点
- Change from Baseline in Inflammatory Lesion Count
研究概览
简要总结
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in Allergan study 225678-004
排除标准
- •Anticipates the need for surgery or hospitalization during the study
研究组 & 干预措施
Dapsone Formulation A
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
干预措施: Dapsone Formulation A (Drug)
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
干预措施: Dapsone Formulation B (Drug)
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
干预措施: Dapsone Formulation C (Drug)
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
干预措施: Dapsone 5% Gel (Drug)
结局指标
主要结局
Change from Baseline in Inflammatory Lesion Count
时间窗: Baseline, Week 12
次要结局
- Change from Baseline in Non-Inflammatory Lesion Count(Baseline, Week 12)
- Change from Baseline in Total Lesion Count(Baseline, Week 12)
- Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1(Week 12)