Mycosis Culture Collection From Dermatological Isolated
- Conditions
- Nail DiseasesOnychomycosisResistant 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
- patients with clinical suspicion of onychomycosis.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with onychomycosis Terbinafine 250 mg 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. Patients with onychomycosis Amorolfine 50 MG/ML 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. Patients with onychomycosis Itraconazole 200 mg 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. Patients with onychomycosis Ciclopirox Topical Gel 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. Patients with onychomycosis Terbinafine Topical Gel 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.
- Primary Outcome Measures
Name Time Method 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 Events Monitored 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 Toes Week 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
Name Time Method Patient Global Assessment week 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