NCT02460497已完成不适用
Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 2% Solution and Botanical Hair Solution Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia (Ludwig I and II)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change From Baseline in Investigator's Rating of Global Photographs at Week 12
研究概览
简要总结
The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients age 18 to 60 years at the time of enrollment.
- •Women who have self-perceived thinning hair.
- •Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).
排除标准
- •History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
- •Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.
- •3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.
- •Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.
- •Subjects who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.
- •Pregnant or breast-feeding females or women planning to become pregnant during the course of the study
结局指标
主要结局
Change From Baseline in Investigator's Rating of Global Photographs at Week 12
时间窗: At Week 12
The Investigator or a trained grader rated each participant's standardized global photographs for improvement from baseline for parameters like hair thinning, hair growth, impression of scalp hair coverage and overall perception of treatment benefit using a 1-to-7-point Likert scale. The score on the scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree.
次要结局
- Change From Baseline in Participant Rating at Week 12(At Week 12)
- Mean Change From Baseline in Shed Hair Count(At Week 12)
- Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire(At Week 4, 6 and 12)
- Number of Participants With Adverse Events (AEs)(From start of study drug administration up to Week 12)
研究者
研究点 (2)
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