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

N. 143.22

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.

2022-07-20

2025-07-20

2025-12-25

Active (not recruiting)

200

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nail'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-08