A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Percentage of subjects with treatment-related adverse events
研究概览
简要总结
The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.
详细描述
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 18 to 55 years.
- •Able and willing to provide written informed consent.
- •Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-
- •Agree to comply with protocol procedures
排除标准
- •Concomitant diagnosis of non-AGA forms of alopecia.
- •Use of other hair loss treatments within periods specified in protocol.
- •Use of excluded medications as specified in protocol.
- •Diagnosis of other medical conditions as specified in protocol.
- •Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.
研究组 & 干预措施
PP405 0.05% Topical Gel
0.05% Topical Gel applied once daily
干预措施: PP405 0.05% Topical Gel (Drug)
PP405 Topical Vehicle Gel
Placebo Topical Gel applied once daily
干预措施: PP405 Topical Vehicle Gel (Drug)
PP405 0.05% Topical Gel - Open Label Extension
0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension
干预措施: PP405 0.05% Topical Gel (Drug)
结局指标
主要结局
Percentage of subjects with treatment-related adverse events
时间窗: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
Collection of adverse events, treatment emergent adverse events and serious adverse events.
Change in local dermal tolerability as assessed by subject and investigator
时间窗: Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe)
次要结局
- Pharmacokinetics of PP405(Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE)