A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 12
- 主要终点
- Target Area Hair Count (TAHC)
研究概览
简要总结
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.
This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).
This trial will determine if the benefit of using either study product outweighs the risks.
详细描述
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.
This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), 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 270 to 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 or 2% MTS, for 52 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 regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.
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
- Single (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
5% MTF
5% Minoxidil Topical Foam
干预措施: 5% Minoxidil (Drug)
2% MTS
2% Minoxidil Topical Solution
干预措施: 2% Minoxidil (Drug)
结局指标
主要结局
Target Area Hair Count (TAHC)
时间窗: Baseline to Week 24
Number of hairs in the area being examined as measured by macrophotography.
次要结局
- Target Area Hair Count (TAHC)(Baseline to Week 12)