A Multicentre, Randomized, Double-blind, Parallel-group, Controlled Study, to Assess the Efficacy and Safety of P-3074 Cutaneous Spray, Solution, in the Treatment of Male Pattern Baldness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 458
- 试验地点
- 46
- 主要终点
- Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
研究概览
简要总结
The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent before starting any study related procedures;
- •Men 18 to 40 years of age;
- •Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
- •Participants willing to have a tattoo in the target area;
- •Outpatients;
- •Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
- •Ability to co-operate with the Investigator and to comply with the requirements of the entire study.
排除标准
- •Clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality;
- •Participants who had had hair transplant surgery or hair weaving;
- •Clinically relevant abnormal laboratory values indicative of physical illness;
- •Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- •History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;
- •Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
- •Suspicion of malignancy, including prostate cancer;
- •History of infertility or difficulty fathering children;
- •Participants who wish to conceive children during the study or whose sexual partner(s) is pregnant;
- •Participants with active seborrheic dermatitis;
- •History of varicocele;
- •Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers";
- •Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole;
- •Participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents;
- •Use of finasteride or dutasteride within previous 12 months;
- •Light or laser treatment of scalp within previous 3 months;
- •Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
- •History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).
研究组 & 干预措施
P-3074 + Finasteride Placebo
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks.
干预措施: P-3074 (Drug)
P-3074 + Finasteride Placebo
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks.
干预措施: Finasteride Placebo (Drug)
P-3074 Vehicle + Finasteride Placebo
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
干预措施: P-3074 Vehicle (Drug)
P-3074 Vehicle + Finasteride Placebo
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
干预措施: Finasteride Placebo (Drug)
Oral Finasteride + P-3074 Vehicle
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
干预措施: Finasteride (Drug)
Oral Finasteride + P-3074 Vehicle
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
干预措施: P-3074 Vehicle (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
时间窗: Baseline and Week 24
The change from baseline in the TAHC within a 1 cm\^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm\^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
次要结局
- Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12(Baseline and Week 12)
- Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24(Baseline, Week 12 and Week 24)
- Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24(Week 12 and Week 24)
- Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24(Baseline, Week 12 and Week 24)
- Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor(Baseline, Week 12 and Week 24)
- Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24(Weeks 4, 8, 12 and 24)
- Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale(Baseline to Week 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs(From the start of IMP up to 28 weeks)