An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Hallux, Inc.
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Complete Cure at Week 52 in the Target Toe
研究概览
简要总结
The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).
详细描述
Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52.
Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52.
Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period.
Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period.
HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 and females 18 - 75 years of age inclusive
- •Patients with DLSO of at least one great toe
- •Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes
- •Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period
排除标准
- •History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
- •Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
- •Participation in another clinical study of an investigational drug or device within 3 months of screening
- •No administration of oral terbinafine or another oral antifungal within 6 months of screening
- •No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
- •No uncontrolled diabetes mellitus
- •No severe psoriasis or severe atopic dermatitis
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
HSG
Hallux terbinafine subungual gel
干预措施: Hallux Terbinafine Subungual Gel (Drug)
结局指标
主要结局
Complete Cure at Week 52 in the Target Toe
时间窗: Week 52
Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).
次要结局
- Clinical Cure in the Target Toe(Week 52)
- Positive Response in the Target Toe(Week 52)
- Mycological Cure in the Target Toe(Week 52)