An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Target Area Hair Count (TAHC)
研究概览
简要总结
Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.
详细描述
This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution in male and female subjects with androgenetic alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia.
- •Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot.
- •Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area.
- •Subjects must agree to maintain the same hair style and hair care regimen during the study.
排除标准
- •Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.
- •Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy.
- •Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety.
研究组 & 干预措施
ATI-50002 Topical Solution
This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI- 50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
干预措施: ATI-50002 (Drug)
结局指标
主要结局
Mean Change From Baseline in Target Area Hair Count (TAHC)
时间窗: Baseline to 26 Weeks
Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.
次要结局
- Mean Change From Baseline in Target Area Hair Count (TAHC)(Baseline to 52 Weeks)
- Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale(Baseline to 52 Weeks)
- Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)(Baseline to 52 Weeks)
- Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale(Baseline to 52 Weeks)
- Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale(Baseline to 52 Weeks)
- Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale(Baseline to 52 Weeks)