Mycosis Culture Collection From Dermatological Isolated

NCT05482763 | Active Not Recruiting FDA Drug

• 1 other identifier: N. 143.22
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis; Resistant Infection; Nail Diseases

Keywords

Onychomycosis; Resistant Infection; Nail Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Dermatology life Quality Index (DLQI)

  week 0,12,24,36,52

• Patient Global Assessment

  week 0,12,24,36,52

Other Outcomes (4)

• Rate of correct classification by the test (MALDI-TOF MS profiling) from positive cultures

  Week 0

• Rate of correct classification by KOH Test from clinical isolates

  Week 0

• Rate of correct classification by direct Microscopy Test from positive cultures

  Week 0

Study Arms (1)

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; Drug: Itraconazole 200 mg; Drug: Terbinafine 250 mg; Drug: Ciclopirox Topical Gel; Drug: Amorolfine 50 MG/ML

Interventions

Terbinafine Topical Gel DRUG

Topical application of terbinafine

Patients with onychomycosis

Itraconazole 200 mg DRUG

systemic itraconazole pulse therapy

Patients with onychomycosis

Terbinafine 250 mg DRUG

systemic terbinafine

Patients with onychomycosis

Ciclopirox Topical Gel DRUG

Topical application of ciclopirox

Patients with onychomycosis

Amorolfine 50 MG/ML DRUG

Topical application of amorolfine

Patients with onychomycosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• patients with clinical suspicion of onychomycosis.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Tor Vergata Univerisity Hospital

Rome, 00133, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nail

MeSH Terms

Conditions

Onychomycosis; Nail Diseases

Interventions

Itraconazole; Terbinafine; amorolfine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Elena Campione

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: July 20, 2022
• Primary Completion: July 20, 2025
• Study Completion: December 25, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)