Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mycological assessment
研究概览
简要总结
The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the age of 18 were treated at the Department of Dermatology, IRCCS Azienda Ospedaliero - Universitaria Sant'Orsola in Bologna (Italy) between January 1, 2019, and April 30, 2023. The people were treated as part of their regular medical care with ciclopirox or Mycoclear®. In this observational study, the data are now being reviewed to answer the following questions:
• Does Mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks?
People were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. The doctor did the following main tests during the study period:
- Performing the clinical evaluation
- Checking the lab test for a fungal infection.
- Measuring how much of the nail grows without problems. The results of this study will help dermatologists choose the best treatment for fungal nail infections.
详细描述
In Italy the prevalence of onychomycosis in subjects aged >65 years was as high as 35%. This observational, retrospective study has the objective to evaluate the safety and effectiveness of two treatment for distal and lateral subungual onychomycosis (DLSO), the most prevalent clinical variant of onychomycosis. Two cohorts of patients treated between January 2019, and April 2023 are involved: 40 patients treated with Mycoclear, a medical device that is widely used as an antifungal in outpatient clinical practice and 40 patients treated with ciclopirox, an commonly used antifungal drug. The primary outcomes are the Investigator Global Assessment of Efficacy, mycological assessment, and the extent of healthy nail growth. Safety is evaluated by the incidence of adverse events. Patients were treated for a maximum period of 24 weeks, in accordance with the "standard usual care" of the center and were visited at baseline, week two, four, 12, and 24 (final visit).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years old.
- •Patients clinically and microscopically KOH diagnosed with distal and lateral subungual onychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following OSI
- •Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes
排除标准
- •Other types of onychomycoses.
- •Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.
- •Pregnant woman, lactating woman.
结局指标
主要结局
Mycological assessment
时间窗: 24 weeks
It was assessed by Investigator during the medical examination by KOH staining and collection of a sample for culture. It was scored according the following: negative culture=cure; positive culture=failure.
Investigator Global Assessment of Efficacy
时间窗: 24 weeks
Change from baseline to 24 weeks of nail color, surface, and thickness assessed by the Investigator during the medical examinations and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=excellent improvement.
次要结局
- Patient Global Assessment of Efficacy(24 weeks)
- Patient Assessment of Usability(24 weeks)
- Incidence of adverse events(24 weeks)
研究者
Michela Valeria Rita Starace, MD PhD
Full-time Researcher RTD-B
University of Bologna