A Study of the Efficacy and Safety of Multiple Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects With Androgenetic Alopecia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 917
- 试验地点
- 1
- 主要终点
- Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)
研究概览
简要总结
The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.
详细描述
Androgenetic alopecia is a common, androgen-induced, pattern of progressive loss of scalp hair with an onset at any age after puberty in genetically predisposed people. The influence of androgens on scalp hair growth is mediated by local and systemic conversion of testosterone to dihydrotestosterone , by the enzyme 5 alpha-reductase. 5 alpha-reductase has been shown to exist as 2 isoenzyme forms, Type 1 and Type 2. Type 1 is predominantly located in the skin, both in the hair follicles and sebaceous glands, and is also found in the liver and kidney . Type 2 is the dominant form in male genitalia, including the prostate, although it has also been reported to be present in the inner root sheath of the hair follicle. The presence of both isoenzymes in the hair follicles suggests that both forms are likely to be important in the pathogenesis and treatment of androgenetic alopecia. Inhibition of both Type 1 and Type 2 5 alpha-reductase may be expected to more effectively reduce systemic and local dihydrotestosterone levels than inhibition of either isoenzyme alone.
Finasteride is a selective Type 2 5 alpha-reductase inhibitor that is currently the only approved oral treatment for androgenetic alopecia worldwide. Dutasteride inhibits both Type 1 and Type 2 5alpha-reductase and is approved in more than 80 countries for the treatment of benign prostatic hyperplasia, and in Korea for the treatment of hair loss. Dutasteride is approximately 3 times as potent as finasteride at inhibiting Type 2 5 alpha-reductase and more than 100 times as potent at inhibiting Type 1 5 alpha-reductase.
In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Norwood-Hamilton Type III vertex, IV, or V
排除标准
- •History or evidence of hair loss other than androgenetic alopecia
- •Scarring of the scalp
- •Use of dutasteride in previous 18 months
- •Use of finasteride within previous 12 months
- •Hair transplantation or hair weaving within 6 months
- •Use of Minoxidil within previous 6 months
- •Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months
- •Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months
- •Light or laser treatment of scalp within previous 3 months
- •Cosmetic products aimed at improving or correcting signs of hair loss within previous 2 weeks
研究组 & 干预措施
1mg Finasteride
1mg finasteride active plus dutasteride placebo, by mouth once daily
干预措施: 1mg Finasteride active (Drug)
1mg Finasteride
1mg finasteride active plus dutasteride placebo, by mouth once daily
干预措施: Dutasteride placebo (Drug)
0.02mg Dutasteride
0.02mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: 0.02mg dutasteride (Drug)
0.02mg Dutasteride
0.02mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: Finasteride placebo (Drug)
0.1mg Dutasteride
0.1mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: 0.1mg dutasteride (Drug)
0.1mg Dutasteride
0.1mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: Finasteride placebo (Drug)
0.5mg Dutasteride
0.5mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: 0.5mg dutasteride (Drug)
0.5mg Dutasteride
0.5mg dutasteride active plus finasteride placebo, by mouth once daily
干预措施: Finasteride placebo (Drug)
Placebo
1mg finasteride placebo plus dutasteride placebo, by mouth once daily
干预措施: Finasteride placebo (Drug)
Placebo
1mg finasteride placebo plus dutasteride placebo, by mouth once daily
干预措施: Dutasteride placebo (Drug)
结局指标
主要结局
Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)
时间窗: Baseline and Week 24
The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
次要结局
- Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12(Baseline and Week 12)
- Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT(Baseline, Week 12, and Week 24)
- Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT(Baseline, Week 12, and Week 24)
- Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately(Baseline and Week 24)
- Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately(Baseline and Week 24)
- Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT(Baseline and Week 24)
- Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT(Baseline and Week 12)
- Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT(Baseline, Week 12, and Week 24)
- Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT(Baseline, Week 12, and Week 24)
- Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately(Baseline and Week 12)
- Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)(Week 12, Week 24, and Week 26)
- Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)(Baseline and Week 12)
- Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24(Baseline and Week 24)
- Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)(Week 12, Week 24, and Week 26)
- Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24(Baseline, Week 12, and Week 24)
- Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24(Baseline, Week 12, and Week 24)