NCT05560841已完成不适用
Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis
Karo Pharma AB2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline
研究概览
简要总结
Evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having given freely her/his informed, written consent.
- •Patient having a good general health.
- •Age: between 18 and 70 years.
- •Patient with superficial onychomycosis or light to moderate distolateral onychomycosis (without matrix involvement and involvement from 10 to 60%) on at least one great toenail.
- •Patient with positive KOH staining.
- •Patient cooperative and aware of the device modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
- •Patient being psychologically able to understand information and to give their/his/her consent.
- •Patient who agrees to refrain from receiving pedicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
- •Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before screening visit and during all the study.
排除标准
- •Pregnant, breastfeeding woman or woman planning a pregnancy during the study;
- •Patient enrolled in another clinical trial or which exclusion period is not over.
- •Patient having used any systemic antifungal treatment in the last 6 months before screening and/or any topical antifungal treatment in the last months before screening visit.
- •Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk;
- •Patient suffering from a severe or progressive disease (at investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, poor blood circulation HIV, psoriasis, lichen planus, immunosuppressive pathology, moderate and high risk obesity (BMI ≥30);
- •Patient having a known allergy or hypersensitivity to one of the constituents of the investigational device.
- •Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
结局指标
主要结局
To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline
时间窗: Day 180
Mean variation from baseline of the percentage of healthy surface after 6 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.
次要结局
- To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 1 and 3 months of treatment compared to baseline(Day 30, Day 90)
- To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)(Day 90, Day 180)
- To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance(Day 30, Day 90, Day180)
- To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.(Day 7, Day 30, Day 90, Day 180)
- To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.(Day 30, Day 90, Day 180)
- To evaluate the safety of of Nailner Brush 2-in-1(Day 180)
研究者
研究点 (2)
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