A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2/3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Change from baseline in non-vellus target area hair count
研究概览
简要总结
The study is designed to validate efficacy and long term safety of PP405.
详细描述
Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.
- •Able and willing to provide written informed consent
- •Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.
- •Have a modified Norwood-Hamilton score of Type IV or Type V
- •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 and procedures 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
Vehicle Topical Gel
Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52
干预措施: Vehicle Topical Gel (Drug)
PP405 0.05% Topical Gel
PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.
干预措施: PP405 0.05% Topical Gel (Drug)
Vehicle Topical Gel
Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52
干预措施: PP405 0.05% Topical Gel (Drug)
结局指标
主要结局
Change from baseline in non-vellus target area hair count
时间窗: Week 24
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
次要结局
- Change from baseline in the Participant Assessment of Scalp Coverage(Week 24)
- ≥20% increase from baseline in non-vellus target area hair count(week 24)
- Change from baseline in non-vellus target area hair count(Week 12)
- Change from baseline in the Participant Assessment of Scalp Coverage(Week 12)
- ≥20% increase from baseline in non-vellus target area hair count(week 12)