OnychomycosisMYCDERMNCT05482763
Mycosis Culture Collection From Dermatological Isolated
An observational study of Onychomycosis and Resistant Infection, run by University of Rome Tor Vergata at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis, Resistant Infection, Nail Diseases
- What is being tested?
- Terbinafine Topical Gel, Itraconazole 200 mg and Terbinafine 250 mg
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jul 2022to 25 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- patients with clinical suspicion of onychomycosis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Terbinafine Topical Gel, Itraconazole 200 mg, Terbinafine 250 mg, Ciclopirox Topical Gel, Amorolfine 50 MG/ML
- Keywords
- Onychomycosis, Resistant Infection, Nail Diseases
- Medical subject headings
- Onychomycosis, Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine Topical GelDrug
Topical application of terbinafine
Itraconazole 200 mgDrug
systemic itraconazole pulse therapy
Terbinafine 250 mgDrug
systemic terbinafine
Ciclopirox Topical GelDrug
Topical application of ciclopirox
Amorolfine 50 MG/MLDrug
Topical application of amorolfine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Terbinafine Topical Gel; Drug: Itraconazole 200 mg; Drug: Terbinafine 250 mg; Drug: Ciclopirox Topical Gel; Drug: Amorolfine 50 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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).
Measured: Week 52
Secondary outcomes (2)
Change in Dermatology life Quality Index (DLQI)
Evaluation of the quality of life of treated patients before and after treatment (0-30 points)
Measured: 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)
Measured: week 0,12,24,36,52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start20 Jul 2022
- Primary completion20 Jul 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Campione, University of Rome Tor Vergata
- Investigators
- Elena Campione, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482763
- Sponsor's protocol ID
- N. 143.22
- Acronym
- MYCDERM
- Status last verified
- May 2024
- First submitted
- 25 Jul 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05482763
- Acronym / sponsor ID
- MYCDERM / N. 143.22
- Conditions
- Onychomycosis, Resistant Infection, Nail Diseases
- Keywords
- Onychomycosis, Resistant Infection, Nail Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with onychomycosis | – | Drug: Terbinafine Topical Gel, Drug: Itraconazole 200 mg, Drug: Terbinafine 250 mg, Drug: Ciclopirox Topical Gel, Drug: Amorolfine 50 MG/MLAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- patients with clinical suspicion of onychomycosis.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terbinafine Topical GelTopical application of terbinafine | Drug | Patients with onychomycosis |
| Itraconazole 200 mgsystemic itraconazole pulse therapy | Drug | Patients with onychomycosis |
| Terbinafine 250 mgsystemic terbinafine | Drug | Patients with onychomycosis |
| Ciclopirox Topical GelTopical application of ciclopirox | Drug | Patients with onychomycosis |
| Amorolfine 50 MG/MLTopical application of amorolfine | Drug | Patients with onychomycosis |
Primary outcome
Change of Onychomycosis Severity Index (OSI)
Time frame: week 0,12,24,36,52
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)
Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
Time frame: Monitored from screening visit to end of study visit (52 week)
Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Complete Cure at 12 months in the Target Toes
Time frame: Week 52
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).
2 secondary outcomes
Change in Dermatology life Quality Index (DLQI)
Time frame: week 0,12,24,36,52
Patient Global Assessment
Time frame: week 0,12,24,36,52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Campione principal investigator
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onychomycosis and Resistant Infection, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Onychomycosis Severity Index (OSI) (time frame: week 0,12,24,36,52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.