Mycosis Culture Collection From Dermatological Isolated

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2025-12-25

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.

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Detailed Description

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Conditions

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Onychomycosis Resistant Infection Nail Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with onychomycosis

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.

Itraconazole 200 mg

Intervention Type DRUG

systemic itraconazole pulse therapy

Terbinafine 250 mg

Intervention Type DRUG

systemic terbinafine

Ciclopirox Topical Gel

Intervention Type DRUG

Topical application of ciclopirox

Amorolfine 50 MG/ML

Intervention Type DRUG

Topical application of amorolfine

Terbinafine Topical Gel

Intervention Type DRUG

Topical application of terbinafine

Interventions

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Itraconazole 200 mg

systemic itraconazole pulse therapy

Intervention Type DRUG

Terbinafine 250 mg

systemic terbinafine

Intervention Type DRUG

Ciclopirox Topical Gel

Topical application of ciclopirox

Intervention Type DRUG

Amorolfine 50 MG/ML

Topical application of amorolfine

Intervention Type DRUG

Terbinafine Topical Gel

Topical application of terbinafine

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes