Evaluation of the Efficacy of Chesson Labs LIQUICURE™ for Treatment of Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Freedom from major product-related adverse events for the duration of the feasibility phase.
研究概览
简要总结
There is a major clinical need for an inexpensive topically-applied product that can inhibit the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE with a longer drying/curing time that will allow better nail penetration or adsorption. Though the product may have inherent antimicrobial activity, the product does not contain a drug or antimicrobial agent.
Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail fungal infection is defined by negative dermatophyte culture and visual improvement in nail characteristics within six months, with few, if any product-related adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nail fungal infection of at least one great toe [per visual assessment, positive KOH preparation, and positive dermatophyte culture]
- •Subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator
- •2 mm of clear nail proximally on great toenail / no lunula involvement
- •Subject must be physically able to reach toes to clean them and apply product
- •Subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study
- •Subject is willing and available to return for study follow up
- •Ability of the subject or legal representative to understand and provide signed consent for participating in the study
- •Negative urine pregnancy test for women of child bearing age
- •Females must be post menopausal or must agree to use approved contraceptives (actions, devices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (Note: abstinence is NOT an accepted form of contraception)
排除标准
- •Known hypersensitivity or allergy to the product materials
- •Negative KOH preparation or dermatophyte culture
- •Thickness of nail greater than 3 mm
- •Enrollment in another investigational drug or product protocol that would interfere with this study
- •Continuation or use of other topical or pharmaceutical treatments for the condition; a wash-out period of at least four weeks after discontinuation of a topical product or 180 days after discontinuation of an oral product for treatment of nail fungus is required
- •Chronic disease, including: diabetes, psoriasis, immune deficiency, severe foot injury, chronic vascular disease or any other condition that would decrease circulation to the extremities at the discretion of the investigator Pregnant or nursing females
- •Investigators, Chesson personnel, or Chesson Scientific Advisory Board members or their immediate family
研究组 & 干预措施
LIQUICURE
Medical Device
干预措施: LIQUICURE (Device)
结局指标
主要结局
Freedom from major product-related adverse events for the duration of the feasibility phase.
时间窗: Six months
Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics
时间窗: Six months
次要结局
- Time to clearance of infection(6 months)