A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
试验速览
- 阶段
- 2 期
- 发起方
- Neosil, Inc.
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.
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 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men, aged 18 to 49 years, in general good health
- •Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area
排除标准
- •Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- •Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
研究组 & 干预措施
1
NEOSH101 2%
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
2
NEOSH101 1%
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
3
NEOSH101 0.5%
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
4
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
结局指标
主要结局
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
时间窗: 16 weeks application treatment period followed by 12 weeks observation period
次要结局
- Assessment score of dermal tolerability(16 weeks application treatment period followed by 12 weeks observation period)
- Physician's global assessment score(16 weeks application treatment period followed by 12 weeks observation period)