Mycosis Culture Collection From Dermatological Isolated (MYCDERM)

University of Rome Tor Vergata

Status: Active, not recruiting

Conditions: Resistant Infection; Nail Diseases; Onychomycosis

Treatments: Drug: Terbinafine Topical Gel; Drug: Itraconazole 200 mg; Drug: Ciclopirox Topical Gel; Drug: Amorolfine 50 MG/ML; Drug: Terbinafine 250 mg

Study type: Observational

Funder types: Other

Identifiers

NCT05482763

N. 143.22

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients with onychomycosis

Description:

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.

Treatment:

Drug: Itraconazole 200 mg

Drug: Amorolfine 50 MG/ML

Drug: Ciclopirox Topical Gel

Drug: Terbinafine 250 mg

Drug: Terbinafine Topical Gel