A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 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
- 入组人数
- 518
- 试验地点
- 21
- 主要终点
- Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
研究概览
简要总结
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 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
- Double (Participant, Investigator)
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)
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 terbinifine 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
- •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
1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
干预措施: terbinafine (Drug)
2
vehicle (placebo) applied once daily for 48 weeks
干预措施: Placebo (Drug)
3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
干预措施: terbinafine (Drug)
4
vehicle (placebo) applied once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.
时间窗: 52 weeks
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
次要结局
- Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.(52 weeks)
- Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.(52 weeks)
- Number of Participants Assessed With Adverse Events and Serious Adverse Events(52 weeks)