EUCTR2015-002877-40-ES进行中（未招募）1 期
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.
Polichem S.A.0 个研究点目标入组 450 人开始时间: 2016年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Written informed consent before starting any study related procedures;
- •2. Men 18 to 40 years of age;
- •3. Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
- •4. Patients willing to have a tattoo in the target area;
- •5. Outpatients;
- •6. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
- •7. Ability to co-operate with the Investigator and to comply with the requirements of the entire study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as abrasion, actinic keratosis or any abnormal findings in the scalp;
- •2. Patients who had had hair transplant surgery or hair weaving;
- •3. Clinically relevant abnormal laboratory values indicative of physical illness;
- •4. 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;
- •5. History of local infections of skin and subcutaneous tissues of the head in the 3-month period before the trial inclusion;
- •6. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
- •7. Suspicion of malignancy, including prostate cancer;
- •8. History of infertility or difficulty fathering children;
- •9. Patients who wished to father children during the study or whose sexual partner(s) were pregnant;
- •10. Patients with active seborrheic dermatitis;
- •11. History of varicocele;
- •12. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter hair restorers;
- •13. Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone, or ketoconazole;
- •14. Patients 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;
- •15. Use of finasteride or dutasteride within previous 12 months;
- •16. Light or laser treatment of scalp within previous 3 months;
- •17. 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;
- •18. 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).
研究者
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