Onychomycosis Clinical Trial
Official title:
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Lev Yasmin Clinic | Natanya |
Lead Sponsor | Collaborator |
---|---|
MB Mazor Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nail cure as measured by measured by length of healthy nail of at least 5 mm | Cure measured by length of healthy nail of at least 5 mm | 24-30 weeks | No |
Primary | Nail cure as measured by culture and smear | Nail culture and smear | 24-30 weeks | No |
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