Onychomycosis of Toenails
Conditions
Keywords
onychomycosis, medical device, observational study
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).
Interventions
None listed
Sponsors
Dionisio Franco Barattini, MD, MBA, MSc
University of Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Usability | 24 weeks | 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) |
| Patient Global Assessment of Efficacy | 24 weeks | 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. |
| Incidence of adverse events | 24 weeks | 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. |
Countries
Italy
Contacts
Primary ContactMichela Valeria R Starace, MD PhD
Backup ContactLucia A Data Manager, Msc
Outcome results
None listed