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 人开始时间: 2012年8月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
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
研究者
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