Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.
详细描述
Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.
Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.
In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects, investigators, and study staff will not be masked as to the treatment duration assigned to each subject (7 versus 14 days). For subjects receiving the 14-day treatment with study drug, the contents of the study drug (active versus placebo) will be masked to the subject, investigator, and study staff.
入排标准
- 年龄范围
- 25 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated otomycosis of the external ear only, age more than 2 year
排除标准
- •Pregnancy
- •Other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s)
- •Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated
- •Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed
- •Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry
- •Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry
- •Recurrent otomycosis that had been unresponsive to previous antifungal treatment
- •Known hypersensitivity to any of the components in the test formulation
研究组 & 干预措施
7-Day Miconazole Oil (Miconazole 2%)
7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
干预措施: 7-Day Miconazole Oil (Miconazole 2%) (Drug)
14-Day Miconazole Oil (Miconazole 2%)
14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
干预措施: 14-Day Miconazole Oil (Miconazole 2%) (Drug)
14-Day Placebo - Oil Vehicle
14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
干预措施: 14-Day Placebo - Oil Vehicle (Drug)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Percentage of subjects in MITT population, at the "Test of Cure" visit with "Therapeutic cure", defined as a negative fungal culture plus "clinical cure" defined as the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain.
次要结局
- Secondary Efficacy Endpoints(At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle))