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.
Study Type
OBSERVATIONAL
Enrollment
200
Topical application of terbinafine
systemic itraconazole pulse therapy
systemic terbinafine
Topical application of ciclopirox
Topical application of amorolfine
Tor Vergata Univerisity Hospital
Rome, Italy
Change of Onychomycosis Severity Index (OSI)
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)
Time frame: week 0,12,24,36,52
Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Monitored from screening visit to end of study visit (52 week)
Complete Cure at 12 months in the Target Toes
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).
Time frame: Week 52
Change in Dermatology life Quality Index (DLQI)
Evaluation of the quality of life of treated patients before and after treatment (0-30 points)
Time frame: week 0,12,24,36,52
Patient Global Assessment
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)
Time frame: week 0,12,24,36,52
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