Mycosis Culture Collection From Dermatological Isolated

Study Overview
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Brief Summary
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This pilot, prospective, observational drug study aims to evaluate the efficacy, tolerability and safety of topical and oral antifungals in the treatment of onychomycosis caused by yeasts, dermatophytic moulds and non-dermatophytic moulds as well as correlate the scores in the MALDI-TOF method for the 'identification of genus and species of higher fungi utilizing the comparison between identification in direct optical microscopy, culture examination and optical microscopy and macroscopic and onychoscopic clinical aspects. Furthermore, an optional substudy will evaluate the drug resistance of clinical isolates using molecular or genetic methods.

Official Title
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Pilot Study on the Evaluation of the Efficacy, Tolerability and Safety of Topical and Oral Antifungals in the Treatment of Onychomycosis and Creation of a Library of Dermatological Clinical Isolates

Conditions
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Onychomycosis, Resistant Infection, Nail Diseases

Intervention / Treatment
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* Drug: Terbinafine Topical Gel
* Drug: Itraconazole 200 mg
* Drug: Terbinafine 250 mg
* Drug: Ciclopirox Topical Gel
* Drug: Amorolfine 50 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with clinical suspicion of onychomycosis. Exclusion Criteria: Patients deemed unsuitable by the investigator Patients with documented sensitivity to study drugs such as azoles, allylamine, and ciclopirox olamine. Failure to adhere to topical or oral therapy; Replacement of the therapy reported in the study protocol; Voluntary decision by the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with onychomycosis<br>All patients with clinical suspicion of onychomycosis at the Tor Vergata Polyclinic center will be enrolled according to the inclusion and exclusion criteria of the study. After signing the informed consent, the subjects will be subjected to scraping or clipping of the nail unit affected by the disease. The collected material will be stored in a sterile container to be sent to the Microbiology laboratory. | Drug: Terbinafine Topical Gel<br>* Topical application of terbinafine<br>Drug: Itraconazole 200 mg<br>* systemic itraconazole pulse therapy<br>Drug: Terbinafine 250 mg<br>* systemic terbinafine<br>Drug: Ciclopirox Topical Gel<br>* Topical application of ciclopirox<br>Drug: Amorolfine 50 MG/ML<br>* Topical application of amorolfine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Onychomycosis Severity Index (OSI) | Change of Onychomycosis Severity Index (OSI) from baseline to 12 months: Area of Involvement (0-5 points) Proximity of Disease to Matrix (1-5 points) Presence of Dermatophytoma or Subungual Hyperkeratosis 2 mm ( 0 or 10 points) | week 0,12,24,36,52 | 
| Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events | Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE). | Monitored from screening visit to end of study visit (52 week) | 
| Complete Cure at 12 months in the Target Toes | Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture). | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dermatology life Quality Index (DLQI) | Evaluation of the quality of life of treated patients before and after treatment (0-30 points) | week 0,12,24,36,52 | 
| Patient Global Assessment | To establish each patient's impression of DLSO improvement in their target toe over the study period, patients will reference the following scale (0 = clear of DLSO, 1 = marked improvement of DLSO, 2 = moderately improved DLSO, 3 = slightly improved DLSO, 4 = unchanged, 5 = worse) | week 0,12,24,36,52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, Resistant Infection, Nail Diseases