Retrospective observational study in patients with onychomycosis treated with Mycoclear and ciclopirox v1

The prevalence of onychomycosis in adults varies considerably between countries. Ina recent survey conducted in Italy, the prevalence of onychomycosis in subjectsaged >65 years was found to be as high as 35%. The most prevalent clinicalvariant of onychomycosis is distal and lateral subungual onychomycosis (DLSO),which affects both finger and toenails in 58–85% of cases. The fungus (usuallydermatophytes) enters the nail through the distal subungual and lateral nailgroove. The primary objective of this observational, retrospective study is toevaluate the effectiveness of Mycoclear, a medical device widely used as anantifungal in outpatient clinical practice, by the Clinical Cured Index,compared with ciclopirox, an antifungal drug commonly used as a therapeuticoption in dermatology. The data collected pertains to patients who were treatedat the Department of Dermatology at the IRCCS Azienda Ospedaliero-UniversitariaSant'Orsola in Bologna, Italy, between January 1, 2019, and April 30, 2023. Theprimary outcomes are the Investigator Global Assessment of Efficacy,mycological assessment, and healthy nail growth. In accordance with theclinical practice of the involved center, patients are evaluated using theClinical Cure Index as follows: complete cure, partial cure, or no cure.Secondary outcomes are the Patient Global Assessment of Efficacy, the PatientAssessment of Usability, and the incidence of adverse events. Included patientsare men and women aged 18 years or older with distal and lateral subungualonychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of thegreat toenails) evaluated as mild to moderate following OSI. In addition,patients must have positive microscopy (direct KOH) and a positive fungalculture for dermatophytes. It is not permitted for patients to have usedsystemic antifungal agents within the previous six months or topical antifungalagents on toenails within the previous six weeks. Patients were treated for aperiod of six months, in accordance with the clinical practice of the center,and were visited at baseline, week two, four, 12, and 24 (final visit). Thecalculated sample size for the study is 40 patients per group. This study isnot funded by any grants.