NCT00418730已完成2 期
A Phase 2 Multicenter, Randomized, Placebo- and Comparator-Controlled, Double-Blind Parallel Group Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Neosil, Inc.
- 入组人数
- 180
- 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 measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.
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
- •Caucasian men, in general good health, aged 18-49 years
- •Norwood/Hamilton grades III-IV, 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 start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start
研究组 & 干预措施
1
Experimental
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
2
Active Comparator
干预措施: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) (Drug)
3
Placebo Comparator
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: Through Study Day 197
次要结局
- Assessment score of dermal tolerability(Through Study Day 197)
- Physician's global assessment score(Through Study Day 197)
研究者
研究点 (1)
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