An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects With Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Changes in non-vellus Total Area Hair Count (TAHC)
研究概览
简要总结
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA).
AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness.
This multiple center, open-label, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or non-pregnant female aged 18-65 years old;
- •Subject has a clinical diagnosis of mild to moderate AGA;
- •Subject is in good general health and has normal renal and hepatic function;
- •Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
- •Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
- •Subject agrees to have a micro dot tattoo placed on their scalp;
- •Subject agrees to have this area photographed at study visits as indicated in the protocol.
排除标准
- •Subject has uncontrolled blood pressure;
- •Subject has symptoms or history of certain heart or thyroid conditions;
- •Subject has a history of cardiac and/or thyroid diseases;
- •Subject has received an organ transplant;
- •Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening;
- •Subject has a current or recent history of dietary or weight changes;
- •Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
- •Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening;
- •Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening;
- •Subject has had previous radiation of the scalp;
- •Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening;
- •Subject has used systemic beta blockers within 12 weeks prior to screening;
- •Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days prior to screening;
- •Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
研究组 & 干预措施
VDPHL01 Tablet
干预措施: VDPHL01 (Drug)
结局指标
主要结局
Changes in non-vellus Total Area Hair Count (TAHC)
时间窗: Month 12
Change from baseline in non-vellus TAHC using digital image analysis at Month 12.
Subjects Evaluation of Treatment Benefit
时间窗: Month 12
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 12.
次要结局
未报告次要终点