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ACTIVE NOT RECRUITING
NCT05482763

Mycosis Culture Collection From Dermatological Isolated

Sponsor: University of Rome Tor Vergata

View on ClinicalTrials.gov

Summary

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: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2022-07-20

Completion Date

2025-12-25

Last Updated

2024-05-08

Healthy Volunteers

Yes

Interventions

DRUG

Terbinafine Topical Gel

Topical application of terbinafine

DRUG

Itraconazole 200 mg

systemic itraconazole pulse therapy

DRUG

Terbinafine 250 mg

systemic terbinafine

DRUG

Ciclopirox Topical Gel

Topical application of ciclopirox

DRUG

Amorolfine 50 MG/ML

Topical application of amorolfine

Locations (1)

Tor Vergata Univerisity Hospital

Rome, Italy