A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,029
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.
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
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females 12 - 75 years of age
- •Fungal toenail infection of one or both of the large (great) toenails
- •The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
- •The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.
排除标准
- •Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
- •Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
- •No administration of systemic antifungal medications within 6 months prior to screening visit
- •No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- •Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- •Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
- •No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
- •Known pregnancy or lactation at time of enrollment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Terbinafine
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
干预措施: terbinafine hydrogen chloride (Drug)
Amorolfine
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
干预措施: amorolfine nail lacquer (Drug)
结局指标
主要结局
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
时间窗: Week 52
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
时间窗: Week 52
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
次要结局
- Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks(Week 52)
- Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.(Week 52)
- Safety and Tolerability Assessed by the Number of Participants With Adverse Events(Week 52)