Mycosis Culture Collection From Dermatological Isolated

Onychomycosis Clinical Trial

— MYCDERM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482763
• Other study ID #: N. 143.22
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Nail Diseases
• Onychomycosis
• Resistant Infection

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