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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02436291 |
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Date of registration:
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28/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
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Scientific title:
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Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02436291 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Avner Shemer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dermatology Clinic Natanya Israel |
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Name:
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Avner Shemer, MD |
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Address:
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Telephone:
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972-9-8655533 |
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Email:
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Affiliation:
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Name:
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Ofer Mazor |
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Address:
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Telephone:
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972-52-8566789 |
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Email:
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ofmazor@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Onychomycosis
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Intervention(s)
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Device: CURE-EX device
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Primary Outcome(s)
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Nail cure as measured by culture and smear
[Time Frame: 24-30 weeks]
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Nail cure as measured by measured by length of healthy nail of at least 5 mm
[Time Frame: 24-30 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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