A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Fungal culture result
研究概览
简要总结
This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.
详细描述
A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.
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
- •Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
- •T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site
排除标准
- •Women who are pregnant or nursing or planning on becoming pregnant
- •Subjects with onychomycosis or moccasin-type t. pedis
- •Subjects using topical or systemic anti-fungal agents
研究组 & 干预措施
SB208 2%
Apply once daily to one or both feet for 14 days
干预措施: SB208 2% (Drug)
SB208 4%
Apply once daily to one or both feet for 14 days
干预措施: SB208 4% (Drug)
SB208 16%
Apply once daily to one or both feet for 14 days
干预措施: SB208 16% (Drug)
Vehicle Gel
Apply once daily to one or both feet for 14 days
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Fungal culture result
时间窗: 2 weeks
Negative fungal culture from target lesion
次要结局
- Clinical cure(6 wks)
- Mycological cure(6 wks)