ACTRN12613000974707已完成1 期
A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia
Samumed LLC0 个研究点目标入组 30 人开始时间: 2013年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •Males between 18 and 60 years of age, inclusive
- •Diagnosed with androgenetic (AGA) alopecia with a Norwood-Hamilton Classification score of 4, 5, 6 or 7.
- •In good general health
- •Willing and able to attend study visits
- •Willing to maintain same hair style for the duration of the study
- •Willing to use a sponsor supplied shampoo and conditioner for the duration of the study
- •Able to comprehend and willing to sign an informed consent form
排除标准
- •Clinical diagnosis of alopecia areata or other non-AGA form of alopecia.
- •Scalp hair loss, on the treatment area, due to disease, injury or medical therapy.
- •Males who are sexually active and have a partner that is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically implanted hormonal therapy, intrauterine devices or oral birth control with barrier method).
- •Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the investigator, might put the subject at risk or interfere with the study conduct or evaluations.
- •History of surgical correction of hair loss on the scalp.
- •Use of finasteride or dutasteride within the 12 weeks prior to the Screening Visit.
- •Use of minoxidil within the 12 weeks prior to the Screening Visit.
- •Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyperoterone acetate, cimetidine) within 12 weeks prior to the Screening Visit.
- •Use of any scalp hair growth products within the 12 weeks prior to the Screening Visit.
- •History of hair transplants.
- •Current use of an occlusive wig, hair extensions or hair weaves
- •History of hypersensitivity or allergies to any ingredient of the study medications.
- •Participation in any other investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening Visit.
- •Poor peripheral venous access.
- •Subjects with a history of clinically significant cardiac arrhythmia as determined by the principal investigator.
- •Subjects with clinically significant findings from medical history, clinical laboratory tests, ECG and vital signs that, in the opinion of the investigator, could interfere with the objectives of the study or put the subject at risk.
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