Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
研究概览
简要总结
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.
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
- 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
- •Subject having given her/his informed, written consent,
- •Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
- •Subject being psychologically able to understand information and to give their/his/her consent.
- •Age: more than 18 years.
- •Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
- •Subject with positive results of KOH staining.
- •Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
- •Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
排除标准
- •Subject considered by the Investigator likely to be non-compliant with the protocol.
- •Patient enrolled in another clinical trial during the test period.
- •Woman being pregnant, nursing or planning a pregnancy during the course of this study.
- •Subject having a known allergy to one of the constituents of the tested products.
- •Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology....
- •Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
研究组 & 干预措施
Excilor
2 applications per day for 6 months
干预措施: Excilor (Device)
Loceryl 5%
1 application per week for 6 months
干预措施: Loceryl 5% (Drug)
结局指标
主要结局
At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
时间窗: After 168 days of treatment
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
次要结局
- At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.(After 14, 28, 56 and 112 days of treatment)
- Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.(On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168)
- Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).(After 14, 28, 56 and 112 days of treatment)
- Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.(On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168)
- Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.(On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168)
- Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.(On baseline (day zero) and day 168)