An observational study in Onychomycosis of Toenails, sponsored by University of Bologna. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by University of Bologna · Observational
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:
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:
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).
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 11 observational studies indexed under Onychomycosis.
Browse Onychomycosis studies →University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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Normal outpatients affected by distal and lateral subungual onychomycosis (DLSO) and visited in the Department of Dermatology at the IRCCS Azienda Ospedaliero-Universitaria Sant'Orsola in Bologna, Italy, between January 1, 2019, and April 30, 2023
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mycoclear® was topically administered as indicated in the instructions for use of the product for a maximum of 24 weeks
Ciclopirox was topically administered as indicated in the instructions for use of the product for a maximum of 24 weeks
Investigator Global Assessment of Efficacy
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.
Time frame: 24 weeks
Mycological assessment
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.
Time frame: 24 weeks
Patient Global Assessment of Efficacy
Change from baseline to the final 24 week visit of global treatment effectiveness assessed by the patient and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=good improvement; 3=excellent improvement.
Time frame: 24 weeks
Patient Assessment of Usability
The patient responds to a usability questionnaire for the tested medical device. The questionnaire items will be scored by an ordinal scale (ranging from 1-10) where 1 = poor rating, and 10 = excellent rating)
Time frame: 24 weeks
Incidence of adverse events
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) for the two products will be collected by Investigators only if they were not reported as part of clinical practice in the previous visits performed on the patients.
Time frame: 24 weeks
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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