Onychomycosis, Resistant Infection, Nail Diseases
Conditions
Keywords
Onychomycosis, Resistant Infection, Nail Diseases
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.
Interventions
DRUGTerbinafine Topical Gel
Topical application of terbinafine
systemic itraconazole pulse therapy
systemic terbinafine
DRUGCiclopirox Topical Gel
Topical application of ciclopirox
DRUGAmorolfine 50 MG/ML
Topical application of amorolfine
Sponsors
University of Rome Tor Vergata
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of correct classification by KOH Test from clinical isolates | Week 0 | For each clinical sample, the status (correct or incorrect) of the classification of the sample (infected or not infected) by the KOH test will be determined. Then the rate of correct classification will be calculated. The test will be considered efficient when it has reached a correct classification rate of more than 95%. |
| Correlation between the identified fungi pathogens and the clinical course of the participants. | Week 52 | In fungi infected participants, the presence of a correlation between the presence of fungal infection and the clinical evolution of patients will be determined. |
| Rate of correct classification by direct Microscopy Test from positive cultures | Week 0 | For each culture positive clinical sample, the status (correct or incorrect) of the classification of the sample (infected or not infected) by the test (Microscopy of the cultures) will be determined. Then the rate of correct classification will be calculated. The test will be considered efficient when it has reached a correct classification rate of more than 95%. |
| Rate of correct classification by the test (MALDI-TOF MS profiling) from positive cultures | Week 0 | For each culture positive clinical sample, the status (correct or incorrect) of the classification of the sample (infected or not infected) by the test (MALDI-TOF MS profiling) will be determined. Then the rate of correct classification will be calculated. The test will be considered efficient when it has reached a correct classification rate of more than 95%. |
Countries
Italy
Outcome results
None listed