NCT03351322已完成2 期
A Randomized, Double-Blind, Active-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F701 Solution in Female Subjects With Hair Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The amount of hair loss
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged at least 20 years old
- •With hair loss over 100 hairs/day
- •Willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing ICF and throughout the study
- •The subject of childbearing potential must show a negative urine or serum pregnancy test at Screening Visit
- •Have signed the written informed consent form
排除标准
- •Any subject meeting any of the exclusion criteria will be excluded from study participation.
- •With alopecia areata or cicatricial alopecia
- •With other scalp or hair disorders
- •With prior hair transplant
- •Use wigs or hair weaves
- •Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study
- •Have taken any topical or systemic prescription of OTC medications for treating hair loss, hair regrowth and/or hair volume
- •Have used medications known to cause hair thinning, such as Coumadin and anti-depressants/anti-psychotics
- •Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp
- •Have initiated or terminated the use of hormones for birth control or hormone replacement therapy within 6 months. Subject will also be excluded from the study if she plans to initiate or terminate the use of hormones for birth control or hormone replacement therapy during the study.
- •With known or suspected hypersensitivity any ingredients of study product and active control
- •Any hematologic abnormalities.
- •Any serum chemistry abnormalities.
- •Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control.
- •Enrollment in any investigational drug trial
- •With any condition judged by the investigator that entering the trial may be detrimental to the subject
研究组 & 干预措施
ENERGI-F701
Experimental
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
干预措施: ENERGI-F701 (Drug)
Regaine
Active Comparator
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
干预措施: Regaine (Drug)
结局指标
主要结局
The amount of hair loss
时间窗: Week 12
Change of the amount of hair loss at Week 12 from baseline.(hair loss is defined as the collection of hairs after combing at the study site)
次要结局
- The amount of hair loss at each post-treatment visit(Week 2, 4, 6, 8, 10)
- The thickness and density of hair(Week 2, 4, 6, 8, 10, 12)
- Investigator assessment at each post-treatment visit(Week 2, 4, 6, 8, 10, 12)
- The hair wash/shed hair count at each post-treatment visit(Week 2, 4, 6, 8, 10, 12)
- The subject satisfaction(Week 2, 4, 6, 8, 10, 12)
研究者
研究点 (1)
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