Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.
详细描述
Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population. This disorder, although more visible in men, is suffered by both men and women. Recent studies show that the stress experienced by patients with alopecia can be similar or greater than that suffered by a more serious or chronic disease. For all these reasons, alopecia can prefer a social problem without a definitive therapeutic solution.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit. The lipid nature of the formulation and the droplet size of between 150-300 nm means that the emulsion drops easily penetrate the hair follicle and accumulate in the sebaceous glands of said follicles.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind placebo controlled
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
- •• - Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months.
- •- Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form.
- •- Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study.
排除标准
- •• - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors.
- •- Patients with severe hepatic insufficiency.
- •- Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months.
- •- Patients unable to understand the objective of the study or to give informed consent.
- •- Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study.
- •- Patients with a history of drug addiction and drug addictions.
- •- Patients who are participating in another clinical trial.
- •- Patients whose partner is pregnant
研究组 & 干预措施
experimental drug
0.15% w/w dutasteride topical O/W emulsion.
干预措施: Dutasteride (Drug)
Placebo
vehicle (excipients)
干预措施: Placebo (Other)
结局指标
主要结局
Safety and Tolerability
时间窗: 7 months
Local adverse events (AEs) and systemic adverse reactions - Hair microbiome analysis
次要结局
- Efficacy in hair loss reduction(7 months)