A Proof-Of-Concept Phase 1b/2a Randomized, Vehicle, and Comparator-Controlled Study of Topical DLQ01 to Assess the Safety and Efficacy in the Treatment of Androgenetic Alopecia (AGA) in Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- TAHC (total, terminal, and vellus)
研究概览
简要总结
The goal of this study is to measure the safety, tolerability, and the hair growth response to topical DLQ01 solutions in comparison to the vehicle and a comparator solution in 120 males with Androgenetic Alopecia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with active AGA on the vertex area of the scalp consistent with Norwood-Hamilton Grades of IIIv through V, excluding IIIa, IVa, and Va grades.
- •Willing to maintain the same hair style, approximate length, and hair colour throughout the duration of the study as documented in the global photograph at Day -2 of baseline.
- •Willing to have target areas shaved and to have temporary dot tattoos placed on their scalp.
- •Willing to comply with the study instructions and return to the site for required visits.
- •Must be willing and able to communicate and participate in the entire study and willing to use an electronic diary to record investigational product dosing.
- •Must provide written informed consent.
排除标准
- •Participants with other type of alopecia other than AGA or any other concomitant skin or systemic disorder involving the scalp area.
- •Participants with sensitive, irritated, or abraded scalp area.
- •Participants who have undergone hair transplants or have had scalp reductions.
- •Concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol
- •Current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions.
- •History of relevant sensitivity to any of the study products, or components thereof, or a history of drug or other allergy that contraindicates study participation.
- •Known allergy or sensitivity to tattoo ink.
- •Participant with relevant active or prior history of malignancies.
- •Participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease.
- •History of any relevant alcoholism, substance or drug abuse-related disorders in the past year or a positive toxicology screening panel, or alcohol breath test at Screening.
- •Clinically significant abnormal biochemistry, haematology or urinalysis values.
- •Any other relevant serious illness or medical, physical, or psychiatric condition(s) that, could interfere with full participation in the study, pose a significant risk to the participant; or interfere with interpretation of study data.
研究组 & 干预措施
DLQ01 high dose
Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects
干预措施: prostaglandin F2a analogue in vehicle solution high dose (Drug)
DLQ01 low dose
Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects
干预措施: prostaglandin F2a analogue in vehicle solution low dose (Drug)
active ingredient-free vehicle solution to DLQ01
Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects
干预措施: active ingredient-free vehicle solution to DLQ01 (Drug)
Minoxidil Solution 5%
Twice daily application of the comparator cutaneous solution in 30 subjects
干预措施: Minoxidil 5% Topical Solution (Drug)
结局指标
主要结局
TAHC (total, terminal, and vellus)
时间窗: 28 weeks
Change from baseline in total, terminal, and vellus target area hair counts (TAHC) using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit
Cumulative hair thickness density (mm/cm2)
时间窗: 28 weeks
Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
Anagen/telogen ratio
时间窗: 28 weeks
Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
次要结局
- Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline(28 weeks)
- Number of participants with clinically significant abnormal ECG readings(28 weeks)
- Number of participants with clinically significant abnormal laboratory test results(28 weeks)
- Number of participants with clinically significant abnormal blood pressure(28 weeks)
- Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194(28 weeks)
- Number of participants with clinically significant abnormal heart rate(28 weeks)
- Frequency of scores for cutaneous reactions in the treated area through study day 194(28 weeks)
- Plasma concentrations of DLQ01(24 weeks)