Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mycological Cure at 48 Weeks
研究概览
简要总结
This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.
详细描述
Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48 weeks once approved for participation. Analysis will be attained via potassium hydroxide examination (KOH test), nail culture, PCR analysis, and photographic imaging. Subjects may have both hallux nails sampled at screening for culture and KOH testing if both hallux nails appear to meet the criteria for study inclusion. Only subjects with both a positive culture and KOH examination will start study treatment. Subjects may have repeat KOH and culture testing both performed if the first screening test results in at least one of the tests being negative. At investigator's discretion, other affected toenails besides the study target hallux nail may be treated but will not be included for analysis. Patients will come for in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12, week 24, week 36, week 48, and week 52.
If subjects achieve complete cure (as defined by mycological cure and 0% nail involvement) prior to Week 48, patients will be encouraged to continue in the trial with active treatment for the full protocol.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 years old and above
- •Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
- •Positive culture for dermatophytes and positive potassium hydroxide examination
- •Provide signed and dated informed consent
- •Willing to comply with all study procedures and available for the duration of the study
排除标准
- •Known allergic reaction to the study products
- •Unable to provide signed and dated informed consent form
- •Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
- •Thickness of mycotic nail is greater than 3mm
- •Less than 2mm of clear nail at the proximal aspect
- •History of rheumatoid arthritis
- •Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
- •Unwilling or unable to limit use of nail polish for duration of study
- •Known history of PVD, immune system concerns, or ongoing chemotherapy
- •Severe moccasin tinea pedis
- •Prior systemic antifungal drugs 6 months before study start date
- •Prior topical therapy for toenail fungus 2 months before study start date
- •Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
结局指标
主要结局
Mycological Cure at 48 Weeks
时间窗: Baseline to 48 Weeks
Mycological cure rate at week 48 as defined by negative potassium hydroxide examination and negative culture of the target hallux nail
Clinical Efficacy at 48 Weeks
时间窗: Baseline to 48 Weeks
Clinical efficacy rate at week 48 as defined by less than 10% clinical involvement of the target hallux nail
次要结局
- Percent Change in Area of Nail Involvement(Baseline to 52 Weeks)
- Overall Fungal Species(Baseline to 52 Weeks)
- Growth of Clear Nail(Baseline to 52 Weeks)
- Complete Cure at Week 52(Baseline to 52 Weeks)
- Almost Complete Cure at Week 48(Baseline to 48 Weeks)
- Almost Complete Cure at Week 52(Baseline to Week 52)
- Time to Complete Cure(Baseline to 52 Weeks)
- Time to Almost Complete Cure(Baseline to 52 Weeks)
- Dermatopyhyte Identification and Characterization(Baseline to 52 Weeks)
- Complete Cure at Week 48(Baseline to 48 Weeks)
- Mycological Cure Rate(Baseline to 52 Weeks)