NCT01093118终止2 期
A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TMI-358 in the Treatment of Distal Subungual Onychomycosis of the Toenail
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Cure rates
研究概览
简要总结
The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age, inclusive
- •Diagnosed with distal subungual onychomycosis (DSO) of the toenails
- •Great toe(s) with intact skin and intact neurologic functions
- •Great toenail(s) free of nail polish
- •At least one target great toe which has:
- •25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate)
- •at least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement
- •nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm
- •a positive KOH and culture
排除标准
- •Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
- •Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
- •In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
- •History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
- •Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.)
- •Have white superficial onychomycosis, proximal subungual onychomycosis, yellow spikes, or dermatophytoma
- •Have paronychia
- •Have a history of chronic alcohol or drug abuse
研究组 & 干预措施
TMI-358
Experimental
Active treatment
干预措施: TMI-358 (Drug)
MMI-467
Placebo Comparator
干预措施: MMI-467 (Drug)
结局指标
主要结局
Cure rates
时间窗: 48 weeks
Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment.
次要结局
未报告次要终点
研究者
研究点 (6)
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