A Double-Blind, Randomized, Placebo-Controlled Trial of the Efficacy and Safety of 5 Percent Minoxidil Foam in the Treatment of Androgenetic Alopecia in Males
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
研究概览
简要总结
The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.
详细描述
Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial. Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for up to one year.
The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in the primary efficacy measure of mean change in the non-vellus hair count in the target region between Baseline and Week 16, and the subject rating assessed an overall improvement from Baseline.
The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy endpoints of scores from the expert panel review of hair regrowth when comparing photographs obtained at Baseline with photographs obtained at Week 16, as well as the percent change from Baseline in non-vellus hair counts within a pre-specified area of clipped hair.
The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was similar between groups, and no safety concerns were raised based on clinical laboratory test results, vital signs or scalp irritation scores.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
- •Male sex, age 15 to 49, good health
- •Willingness to have a dot tattoo placed in the target area of the scalp during the study
- •Willingness to maintain normal shampooing habits and products during the study
- •Willingness to maintain the same hair style, approximate length, and hair color throughout the study
排除标准
- •Known sensitivity to the investigational product
研究组 & 干预措施
1
Topical 5% minoxidil foam formulation used twice daily
干预措施: minoxidil (Drug)
结局指标
主要结局
Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
时间窗: Baseline to 16 Weeks
次要结局
- Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs(Baseline vs Week 16)
- Clinical safety assessments, including weight, blood pressure, pulse and adverse events(Every eight weeks, up to one year)
- Visual assessment of local dermatitis(Each visit, Baseline through Week 16)
- Vital Signs(Each visit, Baseline through Week 16)
- Percent change from baseline in non-vellus hair counts within a specified area of clipped hair(Baseline vs Week 16)
- Adverse Events(Each visit, Baseline through Week 16)
- Laboratory Tests (hematology, chemistries, and urinalysis)(at Baseline, Week 8, and Week 16 and Final Visit)