Onychomycosis
Conditions
Brief summary
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.
Detailed description
Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.
Interventions
DEVICECURE-EX device
Treatment with CURE-EX device twice daily for 24-30 weeks.
Sponsors
MB Mazor Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear). 2. Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study. 3. Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.
Exclusion criteria
1. lunula infected with onychomycosis. 2. Pregnant or breast feeding female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nail cure as measured by measured by length of healthy nail of at least 5 mm | 24-30 weeks | Cure measured by length of healthy nail of at least 5 mm |
| Nail cure as measured by culture and smear | 24-30 weeks | Nail culture and smear |
Countries
Israel
Contacts
Primary ContactOfer Mazor
Outcome results
None listed