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Mycosis Culture Collection From Dermatological Isolated

Active, not recruiting
Conditions
Nail Diseases
Onychomycosis
Resistant Infection
Interventions
Registration Number
NCT05482763
Lead Sponsor
University of Rome Tor Vergata
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria
  • patients with clinical suspicion of onychomycosis.
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with onychomycosisTerbinafine 250 mgAll 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.
Patients with onychomycosisAmorolfine 50 MG/MLAll 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.
Patients with onychomycosisItraconazole 200 mgAll 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.
Patients with onychomycosisCiclopirox Topical GelAll 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.
Patients with onychomycosisTerbinafine Topical GelAll 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.
Primary Outcome Measures
NameTimeMethod
Change of Onychomycosis Severity Index (OSI)week 0,12,24,36,52

Change of Onychomycosis Severity Index (OSI) from baseline to 12 months:

* Area of Involvement (0-5 points)

* Proximity of Disease to Matrix (1-5 points)

* Presence of Dermatophytoma or Subungual Hyperkeratosis 2 mm ( 0 or 10 points)

Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse EventsMonitored from screening visit to end of study visit (52 week)

Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE).

Complete Cure at 12 months in the Target ToesWeek 52

Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).

Secondary Outcome Measures
NameTimeMethod
Patient Global Assessmentweek 0,12,24,36,52

To establish each patient's impression of DLSO improvement in their target toe over the study period, patients will reference the following scale (0 = clear of DLSO, 1 = marked improvement of DLSO, 2 = moderately improved DLSO, 3 = slightly improved DLSO, 4 = unchanged, 5 = worse)

Change in Dermatology life Quality Index (DLQI)week 0,12,24,36,52

Evaluation of the quality of life of treated patients before and after treatment (0-30 points)

Trial Locations

Locations (1)

Tor Vergata Univerisity Hospital

🇮🇹

Rome, Italy

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