Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Allergan
- 主要终点
- Plasma Levels of Dapsone
研究概览
简要总结
This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate acne on the face
- •Willing to avoid swimming during the study
- •Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study
- •Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study
排除标准
- •Severe cystic acne
- •Use of topical or oral retinoids within 4 weeks
- •Use of isotretinoin within 3 months
- •Use of dapsone or adapalene within 3 months
- •Anticipated need to engage in activities/exercise that would cause profuse sweating
- •Donated blood or equivalent blood loss within 90 days
研究组 & 干预措施
Fixed Combination dapsone/adapalene Formulation A Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
干预措施: Fixed Combination dapsone/adapalene Formulation A Gel (Drug)
Fixed Combination dapsone/adapalene Formulation B Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
干预措施: Fixed Combination dapsone/adapalene Formulation B Gel (Drug)
dapsone 5% gel (ACZONE®)
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
干预措施: dapsone 5% gel (Drug)
adapalene 0.3% gel (Differin®)
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
干预措施: adapalene 0.3% gel (Drug)
结局指标
主要结局
Plasma Levels of Dapsone
时间窗: Day 14
Plasma Levels of Adapalene
时间窗: Day 14
次要结局
- Local Dermal Tolerability Rating Using a 4-Point Scale(Day 14)