A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 27
- 主要终点
- Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.
详细描述
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of DSO for at least one great toenail
- •Direct microscopy of subungual debris positive for hyphal elements (KOH test)
- •Culture confirmation of the growth of a dermatophyte
- •Good general health
- •Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails
- •Willing to refrain from receiving pedicures for the duration of the study
- •If female, using an acceptable form of birth control
排除标准
- •Unable to apply test product onto toenails by him/herself
- •Use of topical antifungal agents on the nail within 1 month
- •Uncontrolled diabetes
- •Onychomycosis of the fingernails
- •Confirmed non-dermatophyte infection of the target toenail
- •Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
- •History of severe or chronic immunosuppression, an immunocompromised condition
- •Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis
- •Psoriasis of the toenails
- •Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings
研究组 & 干预措施
HTU-520 Patch
Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.
干预措施: HTU-520 Patch (Drug)
Placebo Patch
Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.
干预措施: Placebo Patch (Other)
结局指标
主要结局
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
时间窗: 48 Weeks
次要结局
未报告次要终点