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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05482763
Other study ID # N. 143.22
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 20, 2022
Est. completion date December 25, 2025

Study information

Verified date May 2024
Source University of Rome Tor Vergata
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 25, 2025
Est. primary completion date July 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Terbinafine Topical Gel
Topical application of terbinafine
Itraconazole 200 mg
systemic itraconazole pulse therapy
Terbinafine 250 mg
systemic terbinafine
Ciclopirox Topical Gel
Topical application of ciclopirox
Amorolfine 50 MG/ML
Topical application of amorolfine

Locations

Country Name City State
Italy Tor Vergata Univerisity Hospital Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other 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%. Week 0
Other 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%. Week 0
Other 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%. Week 0
Other 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. Week 52
Primary 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)
week 0,12,24,36,52
Primary 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). Monitored from screening visit to end of study visit (52 week)
Primary 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). Week 52
Secondary Change in Dermatology life Quality Index (DLQI) Evaluation of the quality of life of treated patients before and after treatment (0-30 points) week 0,12,24,36,52
Secondary 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) week 0,12,24,36,52
See also
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