Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 77
- 主要终点
- Maximum Plasma Level (Cmax) of Dapsone
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acne vulgaris
- •Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
- •If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
- •willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
排除标准
- •Oral acne treatments within 6 months
研究组 & 干预措施
Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
干预措施: Dapsone Formulation A (Drug)
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
干预措施: Dapsone Formulation B (Drug)
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
干预措施: Dapsone Formulation C (Drug)
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
干预措施: Dapsone 5% Gel (Drug)
结局指标
主要结局
Maximum Plasma Level (Cmax) of Dapsone
时间窗: Day 28
Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.
次要结局
- Maximum Plasma Level (Cmax) of Dapsone Metabolites(Day 28)