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 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
Topical Vehicle Gel, then PP405 0.05% Topical Gel
Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension.
干预措施: Topical Vehicle Gel (Drug)
Topical Vehicle Gel, then PP405 0.05% Topical Gel
Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension.
干预措施: PP405 0.05% Topical Gel (Drug)
PP405 0.05% Topical Gel
PP405 0.05% Topical Gel applied once daily for 28 days.
干预措施: PP405 0.05% Topical Gel (Drug)
结局指标
主要结局
Percentage of Subjects With Adverse Events
时间窗: Baseline to Day 84 of the randomized portion of the study
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Percentage of Subjects With Adverse Events
时间窗: Baseline to Day 84 of the open label extension portion of the study
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
时间窗: Post-dose at day 28 of the randomized portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
时间窗: Post-dose at day 84 of the open label extension portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change From Baseline in Blood Pressure
时间窗: Baseline to Day 84 of the randomized portion of the study
Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)
Change From Baseline in Pulse Rate
时间窗: Baseline to Day 84 of the randomized portion of the study
Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Temperature
时间窗: Baseline to Day 84 of the randomized portion of the study
Change from baseline in temperature in the safety analysis population (day 84 minus baseline)
Change From Baseline in Respiratory Rate
时间窗: Baseline to Day 84 of the randomized portion of the study
Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Weight
时间窗: Baseline to Day 84 of the randomized portion of the study
Change from baseline in weight in the safety analysis population (day 84 minus baseline)
Change From Baseline in Blood Pressure
时间窗: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Pulse Rate
时间窗: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Temperature
时间窗: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Respiratory Rate
时间窗: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Weight
时间窗: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
时间窗: Baseline to day 28 of the randomized portion of the study
Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)
Change From Baseline in Electrocardiogram (ECG) Results
时间窗: Baseline to day 28 of the randomized portion of the study
Electrocardiograms results were compared to baseline (day 28 minus baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
时间窗: Baseline to day 84 of the open label extension portion of the study
Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)
Change From Baseline in Electrocardiograms (ECGs)
时间窗: Baseline to day 84 of the open label extension portion of the study
Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)
Abnormal Laboratory Values
时间窗: Day 28 post baseline in the randomized portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Abnormal Laboratory Values
时间窗: Day 84 post baseline in the open label extension portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
次要结局
- Pharmacokinetics of PP405(Baseline to Day 28 of the randomized portion of the study)
- Pharmacokinetics of PP405(Baseline to Day 84 of the open label extension portion of the study)