Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
试验速览
- 阶段
- 3 期
- 入组人数
- 46
- 主要终点
- Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
研究概览
简要总结
Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- 否
入选标准
- •Volunteers of both sexes;
- •Volunteers aged 18-65 years;
- •Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
- •Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
- •Understand, consent and sign the Instrument of Consent of Clarified.
排除标准
- •Pregnancy or risk pregnancy / lactation;
- •Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- •Concomitant nail pathologies (psoriasis, lichen planus, etc.);
- •Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
- •Irritation History to similar products to the investigational product;
- •Treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks);
- •Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.
研究组 & 干预措施
Nailner 2 in 1 + Ciclopirox 8%
Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail.
They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun.
干预措施: Nailner 2 in 1 (Device)
Nailner 2 in 1 + Ciclopirox 8%
Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail.
They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun.
干预措施: Ciclopirox 8% (Drug)
Ciclopirox 8%
Patients should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun.
干预措施: Ciclopirox 8% (Drug)
结局指标
主要结局
Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
时间窗: 90 days
The improvement rate will be by measuring the area of the nail affected in millimeters (millimeters). The measurement will be taken with a ruler in the direction of the width and length of the lesion (mm2)
次要结局
- Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire(45 and 90 days)
- Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination(90 days)
- Number of adverse events reported and related to the product investigational(90 days)