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
Overview
- Phase
- Not Applicable
- Intervention
- Terbinafine Topical Gel
- Conditions
- Onychomycosis
- Sponsor
- University of Rome Tor Vergata
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change of Onychomycosis Severity Index (OSI)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Elena Campione
Principal Investigator
University of Rome Tor Vergata
Eligibility Criteria
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
Arms & Interventions
Patients with onychomycosis
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.
Intervention: Terbinafine Topical Gel
Patients with onychomycosis
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.
Intervention: Itraconazole 200 mg
Patients with onychomycosis
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.
Intervention: Terbinafine 250 mg
Patients with onychomycosis
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.
Intervention: Ciclopirox Topical Gel
Patients with onychomycosis
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.
Intervention: Amorolfine 50 MG/ML
Outcomes
Primary Outcomes
Change of Onychomycosis Severity Index (OSI)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Patient Global Assessment(week 0,12,24,36,52)
- Change in Dermatology life Quality Index (DLQI)(week 0,12,24,36,52)