A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare clinical improvement before and after treatment
研究概览
简要总结
Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.
详细描述
5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure growth of hair by Global photograph, Microscope hair count, micrometer and record case and side effect during 10 months of treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )
排除标准
- •Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency
- •Psychologic disorder trichotillomania
- •Diet control
- •Pregnancy or lactation
- •On supplement diet within 3 month prior to trial
研究组 & 干预措施
Chelate zinc suppliment
15mg Chelate zinc suppliment : additional to standard 5% minoxidil
干预措施: 15 mg Chelate zinc supplement (Drug)
Placebo drug
Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil
干预措施: Placebo drug supplement (Drug)
结局指标
主要结局
Compare clinical improvement before and after treatment
时间窗: 6 month
Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
Compare hair density before and after treatmen
时间窗: 6 month
Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.
Compare average hair shaft diameter before and after treatment
时间窗: 6 month
Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.
次要结局
- Number of pateint with Side effect(6 month)
研究者
Rattapon Thuangtong
Associate Professor
Siriraj Hospital