A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 16
- 主要终点
- Target Area Hair Count
研究概览
简要总结
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
详细描述
This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.
This clinical trial is designed to compare the risk/benefit profile of the new 5% MTF formulation applied once a day (OD) versus the foam vehicle formulation applied once a day (OD), using objective efficacy measures and safety assessments.
Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 260 complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD, for 24 weeks for efficacy and safety evaluations.
Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.
During the trial following enrollment at Baseline, participants will return to the study site at Weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12 and 24 visits, efficacy assessments will also be conducted, using Target Area Hair Counts (TAHC), measured by macrophotography.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females, age 18 or older in general good health
- •exhibits female pattern hair loss
- •signs and dates an informed consent document
- •agrees to use an adequate method of birth control; if of childbearing potential
- •shows a negative urine pregnancy test at Screening Visit
- •is willing to maintain the same hair style, hair color, and hair regimen throughout the study
- •is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
排除标准
- •hypersensitivity to the (study product), or any ingredients of the (study product)
- •known allergy to hair dye, or hair dye components
- •clinically relevant history of hypotension
- •untreated or uncontrolled hypertension
- •pregnant, planning a pregnancy or nursing a child
- •history of hair transplants
- •currently use hair weaves or non-breathable wigs
- •dermatologic disorders of the scalp that require chronic use of medication for control
- •other types or history of hair loss
- •enrolled in any other investigational medication (drug) study currently, or within the last 6 months
研究组 & 干预措施
Minoxidil Foam
5% Minoxidil Topical Foam
干预措施: 5% Minoxidil Topical Foam (Drug)
Vehicle Foam
Vehicle Topical Foam
干预措施: Vehicle Topical Foam (Drug)
结局指标
主要结局
Target Area Hair Count
时间窗: Baseline to Week 24
Number of hairs in the area being examined as measured by macrophotography.
Subject Assessment of Scalp Coverage
时间窗: Week 24
Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.
次要结局
- Target Area Hair Count(Baseline to Week 12)