A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 44
- 主要终点
- Changes in non-vellus Target Area Hair Counts (TAHC)
研究概览
简要总结
This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).
AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.
This multi-center, double blind, 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).
The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is male 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 is willing and able to swallow study drug whole;
- •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 or orthostatic hypotension;
- •Subject has symptoms or history of certain heart or thyroid conditions;
- •Subject has a history of or active hair loss due to conditions/diseases other than AGA;
- •Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
- •Subject has been diagnosed with COVID-19 within 16 weeks of screening;
- •Subject has had previous radiation of the scalp;
- •Use of any of the following treatments within the indicated washout period before screening:
- •Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
- •Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
- •Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
- •Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
- •Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
- •Subject has used any topical scalp treatments for hair growth within 12 weeks 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;
- •Subject has any other condition that, in the investigator's opinion, interfere with the study
研究组 & 干预措施
VDHPL01 BID
VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
干预措施: VDPHL01 (Drug)
VDPHL01 QD and Placebo QD
Placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
干预措施: VDPHL01 (Drug)
Placebo BID with treatment extension to VDPHL01 BID
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.
干预措施: Placebo (Drug)
Placebo BID with treatment extension to VDPHL01 QD and Placebo QD
Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in non-vellus Target Area Hair Counts (TAHC)
时间窗: Month 6
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects Evaluation of Treatment Benefit
时间窗: Month 6
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 6.
次要结局
未报告次要终点