KCT0005618已完成未知
Double-blind, randomized and placebo-controlled clinical trial on the efficacy and safety of M-200729327-01,02 on hair loss prevention for 24 weeks
Ellead0 个研究点目标入组 43 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 43
研究概览
简要总结
The results of assessment of the number of hairs in the shaved area by phototrichogram showed an increase in the number of hairs in Group A after 16 and 24 weeks of application with statistical significance (p<0.001). Also, the results showed a greater increase in the number of hairs in Group A compared with Group B after 24 weeks of application with statistical significance (p<0.05). The results of visual assessment on the degree of hair loss relief by two researchers (experts) showed a greater improvement (score) in Group A compared with Group B after 16 weeks and 24 weeks of application with statistical significance (p<0.05). Therefore, Sample A was proven to help in hair loss relief after 24 weeks of application.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18?(Year) 至 54?(Year)（—）
- 性别
- All
入选标准
- •?18~54 years old men and women diagnosed with androgenic alopecia.
- •?Androgenic alopecia patients who have been diagnosed as basic type M2, C2, U1 or above, or specific type V1, F1 or above based on Basic and specific (BASP) classification for men and women, stage 3 or above on Norwood-Hamilton scale for men, and stage 1 or above on Ludwig scale for women
- •?Those who do not use special hair growth products and receive hair care and surgical procedure during study period.
- •?Those who are willing to maintain the same hair style, length, and color during the study period.
排除标准
- •?Those who have suffered acute renal, cardiac, or other chronic disease (hypertension or diabetes) that can affect the study results within 6 months.
- •?Those who are pregnant, breast feeding or planning pregnancy within the last 6 months.
- •?Those who have mental disorder.
- •?Those who have infectious skin disease.
- •?Those who received surgical treatments or procedures such as hair transplant or scalp reduction.
- •?Those who have used oral, dutasteride or finasteride within the last 6 months.
- •?Those who have applied topical hair growth products or hair tonic to the scalp within the last 1 month.
- •?Those who have used the following drugs within the last 1 month: steroids, apoptotic agents, vasodilators, antihypertensive drugs, antiepileptics, beta receptor blocker, bronchodilator, diuretic, spironolactone, cimetidine, diazoxide, cyclosporine, and ketoconazole.
- •?Those who have applied topical steroids to scalp within the last 1 months.
- •?Those who have been judged to have difficulty in applying the test product to the scalp because of severe seborrheic dermatitis, psoriasis, and infection of scalp.
- •?Those who have other type of alopecia such as alopecia areata, telogen effluvium, and alopecia cicatrisata besides androgenic alopecia.
- •?Those who have been judged by the study director to be unsuitable for enrollment in this clinical trial.
研究者
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