NCT02150187已完成2 期
Evaluation of the Efficacy of Hcap Formula Nutrition Supplement for Treatment of Men With Androgenic Alopecia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Family Marketing1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
研究概览
简要总结
HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair growth in men with tendencies for hair loss.
详细描述
This study consists of a treatment phase (6 months) and a follow-up phase (6 month ). Eligible subjects will be randomly assigned to receive treatment with the study medication or placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for safety and efficacy evaluations.
HCap Formula or placebo tablets will be taken orally every other day during 6 months.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males between 18-40 years of age.
- •No abnormality in blood tests analysis
- •Present with mild to moderate androgenic alopecia (AGA) graded IIv, IIIv, IV or V according to the Hamilton-Norwood classification
- •Willingness to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study.
- •Willingness to refrain from any therapy affecting hair during the study
- •Willingness to have photographs of the treated area taken.
- •Willingness to follow the treatment schedule and post treatment follow-up.
- •Willingness not participate on other studies during the study course
排除标准
- •Having a known allergy to any of the ingredients in the test products;
- •Participation in a study of another device or drug within one month prior to enrollment or during the study.
- •Hair treatments/ scalp condition
- •Undergone hair transplant surgery, scalp reduction surgery
- •Having hair weave or tattooing of the alopecic area.
- •Other hair loss disorders, such as alopecia areata, scarring alopecia.
- •Suffering from any active dermatological condition in the treated area such as scalp atrophy, which in the opinion of the investigator might interfere with clinical evaluation.
- •Medications
- •Use of the following medications within the past 6 months:
- •Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride).
- •5α-reductase inhibitors for prostate conditions (e.g. benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders
- •Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide)
- •Medications that can potentially cause hypertrichosis (e.g. cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride),
- •Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen.
- •Use of the following medications within the past 3 months:
- •Botanicals/nutraceuticals for hair growth
- •Steroids - systemic steroids for more than 14 days (e.g. corticosteroids, anabolic steroids) or topical steroids on the area of hair loss.
- •Other medical conditions
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), uncontrolled hypertension, symptomatic hypotension, hyper/hypo thyroidism, or pertinent neurological disorders.
- •Suffering from serious medical condition that could adversely affect hair loss such as immunosuppression/immune deficiency disorders (including HIV), history of cancer or having/undergoing any form of treatment for active cancer, connective tissue disorder, inflammatory bowel disease
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
HCap Formula
Experimental
Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.
干预措施: HCap Formula (Dietary Supplement)
Placebo
Placebo Comparator
Same as treatment with placebo pills
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
时间窗: Baseline, 26 Weeks
The primary outcome will be change in the terminal hair count from baseline to 26 Weeks within a 3 cm diameter circle based on macro-photographs of the same area. The treatment group will be compared to the control.
次要结局
- Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately(Baseline, 26 weeks, 52 weeks)
研究者
研究点 (1)
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