An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution
研究概览
简要总结
5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
详细描述
The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •New case male AGA
- •Classification Norwood III vertex or IV
排除标准
- •Have previous AGA treatment in 6 month prior
- •Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
- •Other scalp lesion such as Psoriasis, Tinea capsitis
- •Psychological disorder including trichotillomania
研究组 & 干预措施
5%Minoxidil solution
This arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month.
Record efficacy and safety as described.
干预措施: 5% Minoxidil solution (Drug)
5%Minoxidil milky lotion
This arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described.
干预措施: 5% MInoxidil milky lotion (Drug)
结局指标
主要结局
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution
时间窗: 6 month
1. Target area hair evaluation * Hair density (Digital image, DinoLite pro) * Hair diameter (Electronic outside micrometer) * Hair count vellus/ non-vellus ratio 2. Global photographic review (by 2 Experienced Dermatologist) 3. Patient self evaluation ( 7point scale )
次要结局
- Side effect of topical minoxidil(6 month)
研究者
Rattapon Thuangtong
Assistant Professor
Siriraj Hospital