Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
ConditionOnychomycosis of Toenails
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bologna
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsSponsors and collaborators
University of Bologna
Lead sponsor
Dionisio Franco Barattini, MD, MBA, MSc
Collaborator
Source ClinicalTrials.gov