Mycosis Culture Collection From Dermatological Isolated (MYCDERM)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Onychomycosis; Nail Diseases; Resistant Infection
• Intervention / Treatment: Drug: Terbinafine Topical Gel; Drug: Itraconazole 200 mg; Drug: Terbinafine 250 mg; Drug: Ciclopirox Topical Gel; Drug: Amorolfine 50 MG/ML

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00133
    • Tor Vergata Univerisity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Elena Campione, University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): July 20, 2025
• Study Completion (Estimated): December 25, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Onychomycosis; Resistant Infection; Nail Diseases
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Onychomycosis; Nail Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Amorolfine; Itraconazole; Ciclopirox; Terbinafine
• Other Study ID Numbers: N. 143.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No