Clinical trial NCT06971341: Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
Official title: Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Onychomycosis of Toenails
Keywords: onychomycosis
medical device
observational study
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: Dionisio Franco Barattini, MD, MBA, MSc
First posted: 2025-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Investigator Global Assessment of Efficacy
timeFrame: 24 weeks
measure: Mycological assessment
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient Global Assessment of Efficacy
timeFrame: 24 weeks
measure: Patient Assessment of Usability
timeFrame: 24 weeks
measure: Incidence of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: UOC di Dermatologia - IRCCS Policlinico di Sant'Orsola - Università di Bologna
state: BO
Study officials:
affiliation: Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum - Università di Bologna
name: Bianca M Piraccini, Prof PhD MD
role: STUDY_DIRECTOR
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