NCT05482763

Mycosis Culture Collection From Dermatological Isolated

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Onychomycosis
• Resistant Infection
• Nail Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-20
• Primary completion: 2025-07-20
• Completion: 2025-12-25
• First posted: 2022-08-01
• Last updated: 2024-05-08

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study