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Mycosis Culture Collection From Dermatological Isolated

NCT05482763 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-05-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Elena Campione · University of Rome Tor Vergata

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2025-07-20
Completion
2025-12-25
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482763 on ClinicalTrials.gov