Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox (NCT06971341) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
Italy80 participantsStarted 2025-05-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 OSI6.
* Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.