Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
ConditionOnychomycosis of Toenails
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bologna
About this trial
The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the age of 18 were treated at the Department of Dermatology, IRCCS Azienda Ospedaliero - Universitaria Sant'Orsola in Bologna (Italy) between January 1, 2019, and April 30, 2023. The people were treated as part of their regular medical care with ciclopirox or Mycoclear®. In this observational study, the data are now being reviewed to answer the following questions:
• Does Mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks?
People were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. The doctor did the following main tests during the study period:
* Performing the clinical evaluation * Checking the lab test for a fungal infection. * Measuring how much of the nail grows without problems. The results of this study will help dermatologists choose the best treatment for fungal nail infections.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
Patients clinically and microscopically KOH diagnosed with distal and lateral subungual onychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following OSI6.
Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes
Disqualifiers
Other types of onychomycoses.
Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.
Pregnant woman, lactating woman.
Trial population
Normal outpatients affected by distal and lateral subungual onychomycosis (DLSO) and visited in the Department of Dermatology at the IRCCS Azienda Ospedaliero-Universitaria Sant'Orsola in Bologna, Italy, between January 1, 2019, and April 30, 2023
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Mycoclear®, medical device as antimycotic topical solution
Group B: Ciclopirox, antimycotic drug
Trial outcomes
Primary outcomes
1
Investigator Global Assessment of Efficacy
Change from baseline to 24 weeks of nail color, surface, and thickness assessed by the Investigator during the medical examinations and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=excellent improvement.
Time frame
24 weeks2
Mycological assessment
It was assessed by Investigator during the medical examination by KOH staining and collection of a sample for culture. It was scored according the following: negative culture=cure; positive culture=failure.
Time frame
24 weeksSecondary outcomes
1
Patient Global Assessment of Efficacy
Change from baseline to the final 24 week visit of global treatment effectiveness assessed by the patient and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=good improvement; 3=excellent improvement.
Time frame
24 weeks2
Patient Assessment of Usability
The patient responds to a usability questionnaire for the tested medical device. The questionnaire items will be scored by an ordinal scale (ranging from 1-10) where 1 = poor rating, and 10 = excellent rating)
Time frame
24 weeks3
Incidence of adverse events
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) for the two products will be collected by Investigators only if they were not reported as part of clinical practice in the previous visits performed on the patients.
Time frame
24 weeksSponsors and contacts
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University of Bologna
Lead sponsor
Dionisio Franco Barattini, MD, MBA, MSc
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: