Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Investigator Global Assessment of Efficacy — 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.
• Mycological assessment — 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.

Trial sites (1)

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