The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- linear hair growth rate
研究概览
简要总结
Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 19 years ~ 45 years
- •subjects with AGA (Hamilton&Norwood grad III~IV)
- •subjects who are able to be followed for next 24 weeks.
排除标准
- •subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease
- •subjects with AGA treated with surgical methods (hair TPL)
- •subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months.
- •subjects who took medicine which can affect the hair growth
- •subjects with alopecia other than AGA
研究组 & 干预措施
Sodium valproate
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
干预措施: Valproic Acid (Drug)
Control
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
干预措施: Control placebo (Drug)
结局指标
主要结局
linear hair growth rate
时间窗: 24th week
the average growth rate of hair shaft for 3 days
次要结局
- final hair density(24th week)