An observational study in Onychomycosis, Resistant Infection and Nail Diseases, sponsored by University of Rome Tor Vergata. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Rome Tor Vergata · Observational
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.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 200 is above the median of 81 across 11 observational studies indexed under Onychomycosis.
Browse Onychomycosis studies →University of Rome Tor Vergata is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
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This study involves the collection of biological material from patients with clinical suspicion of onychomycosis at an initial time, baseline T0, prior to the first administration of therapy according to the Italian guidelines, and evaluation with follow-up visits at 3,6,9 and 12 months of treatment (T3-T12).
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Exclusion Criteria:
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.
Drug: Terbinafine Topical Gel · Drug: Itraconazole 200 mg · Drug: Terbinafine 250 mg · Drug: Ciclopirox Topical Gel · Drug: Amorolfine 50 MG/ML
Topical application of terbinafine
systemic itraconazole pulse therapy
systemic terbinafine
Topical application of ciclopirox
Drug page: Amorolfine
Topical application of amorolfine
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
Rate of correct classification by the test (MALDI-TOF MS profiling) from positive cultures
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%.
Time frame: Week 0
Rate of correct classification by KOH Test from clinical isolates
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%.
Time frame: Week 0
Rate of correct classification by direct Microscopy Test from positive cultures
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%.
Time frame: Week 0
Correlation between the identified fungi pathogens and the clinical course of the participants.
In fungi infected participants, the presence of a correlation between the presence of fungal infection and the clinical evolution of patients will be determined.
Time frame: Week 52
Plan to share: No
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This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Rome Tor Vergata