Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change of Trichoscopic parameters (Hair dermoscopy)
研究概览
简要总结
The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases
详细描述
Study approval: The study will be approved by Research and Ethical committee at Faculty of Medicine, Sohag University. Informed written consent will be obtained from all participants after explanation of nature of the study.
Study design: A prospective, randomized, controlled clinical study. Study population: The study will include 45 females aged 15-70 years attending Dermatology outpatient clinic at Sohag University Hospital with a complaint of chronic diffuse hair loss diagnosed clinically and will be confirmed by trichoscope as FPHL and with serum vitamin D deficiency.
Exclusion criteria will include:
- Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
- Oral or parentral vitamin D supplementation for the last 3 months
- Treatment with topical vitamin D analogs in the past month
- Patients who received hair tonics or any specific hair therapy over the last 3 months prior to enrollement in the study.
- Patients with diabetes mellitus, renal disease, thyroid and parathyroid abnormalities, or autoimmune diseases.
- Patients who are pregnant, lactating or on contraceptive pills.
All patients in this study will be subjected to:
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
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All females with FPHL aging 15 - 60 years
排除标准
- •Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
- •Patients with normal serum vit.D level
- •Oral or parentral vitamin D supplementation for the last 3 months
- •Treatment with topical vitamin D analogs in the past month
- •Patients who received hair tonics or any specific hair therapy over the last 3 months prior to enrollement in the study.
- •Patients with diabetes mellitus, renal disease, thyroid and parathyroid abnormalities, or autoimmune diseases.
- •Patients who are pregnant, lactating or on contraceptive pills.
研究组 & 干预措施
Group minoxidil (Treatment group)
Topical application of Minoxidil 5% solution
干预措施: Topical minoxidil (Drug)
Group calcipotriol (Treatment group)
Topical application of vitamin D3 analogue (Calcipotriol ointment)
干预措施: Topical Vitamin D (Drug)
Group 3 (Negative control group)
This group will be given saline
干预措施: Saline spray (Drug)
结局指标
主要结局
Change of Trichoscopic parameters (Hair dermoscopy)
时间窗: 3 months
Measure specific findings of female pattern hair loss diagnosis and follow up after treatment
Change of Sinclaire grading of Female pattern hair loss
时间窗: 3 months
clinical grading of female pattern hair loss
次要结局
未报告次要终点
研究者
Doaa Gaber Abdel baset
Assistant Lecturer
Sohag University