ISRCTN98903916
已完成
未知
Prospective, comparative, pharmacodynamic study of two topical dosage regimens of a new finasteride formulation (0.25% o.d. and b.i.d.) and oral finasteride (1 mg o.d.) after 7 days multiple dose administration in male volunteers with androgenetic alopecia
Polichem S.A. (Switzerland)0 个研究点目标入组 18 人2012年8月8日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Androgenetic alopecia
- 发起方
- Polichem S.A. (Switzerland)
- 入组人数
- 18
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Sex \- male
- •2\. Age: 18\-65 year olds inclusive
- •3\. Androgenetic alopecia: recession of the frontal hairline and hair loss in the vertex or crown or loss of hair over the frontal and vertex scalp regions, corresponding to at least stage 2 of the Hamilton\-Norwood scale
- •4\. BMI: 18, TBMI, T30 kg/m2
- •5\. Vital signs: SBP 100\-139 mmHg, DBP 50\-89 mmHg, HR 50\-90 bpm, measured after 5 min of rest in the sitting position
- •6\. Full comprehension:
- •6\.1\. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
- •6\.2\. Ability to co\-operate with the Investigator and to comply with the requirements of the entire study
- •7\. Informed consent: signed written informed consent prior to inclusion in the study
排除标准
- •1\. ECG (12\-leads) (supine position): clinically relevant abnormalities
- •2\. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study; in particular, skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp
- •3\. Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness
- •4\. Allergy: 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\. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
- •6\. Medications: medications, including over the counter (OTC) drugs, for 2 weeks before the start of the study
- •7\. Investigative drug trials: 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
- •8\. Blood donation: blood donations for 3 months before this study
- •9\. Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>2 drinks/day], caffeine (\>5 cups coffee/tea/day) or tobacco abuse (\<10 cigarettes/day)
- •10\. Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study
结局指标
主要结局
未指定
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