Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Hair Diameter
研究概览
简要总结
The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.
详细描述
This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible individuals will be selected among them. Subjects were randomized to use either Topical Herbal Solution or Topical Minoxidil 5% for 36 weeks.
To our knowledge, this herbal solution for the first time covers all four major causes of AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple mechanism. The application of this new herbal solution for the treatment of AGA should be recommended.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men 18 to 50 years old
- •Written consent
- •Normal general health status
- •Men who have a presentation of androgenetic alopecia (Norwood II - V).
排除标准
- •Use of any topical product in the target region interfering with the study product in the last three months
- •Within the past 6 months receiving of chemotherapy/cytotoxic agents
- •Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
- •Uncontrolled hypertension
- •Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
- •Hormonal diseases such as thyroid disorders, diabetes and, ...
- •Liver and kidney disease
- •History of hair transplants
- •History of surgical correction of hair loss on the scalp
- •Subject having dyed, bleached hair or, with a permanent wave prior to study start.
- •No written consent
研究组 & 干预措施
Treatment group
The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
干预措施: Topical Herbal Solution (Drug)
Treatment group
The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
干预措施: Topical Minoxidil 5% (Drug)
Control group
The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
干预措施: Topical Minoxidil 5% (Drug)
结局指标
主要结局
Change in Hair Diameter
时间窗: baseline, 12, 24, and 36 weeks
Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
次要结局
- Patients Self - Assessment Questionnaire(through study completion)
- Adverse Events(baseline, 12, 24, and 36 weeks)
研究者
Farid Masoud
Principal Investigator
Tabriz University of Medical Sciences