Back to resultsEvaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
CURE-EX device
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
- Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
- Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.
Exclusion Criteria:
- lunula infected with onychomycosis.
- Pregnant or breast feeding female.
Sites / Locations
- Lev Yasmin ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CURE-EX device
Arm Description
twice daily treatment with CURE-EX device for 24-30 weeks
Outcomes
Primary Outcome Measures
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
Nail cure as measured by culture and smear
Nail culture and smear
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02436291
Brief Title
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Official Title
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MB Mazor Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CURE-EX device
Arm Type
Experimental
Arm Description
twice daily treatment with CURE-EX device for 24-30 weeks
Intervention Type
Device
Intervention Name(s)
CURE-EX device
Intervention Description
Treatment with CURE-EX device twice daily for 24-30 weeks.
Primary Outcome Measure Information:
Title
Nail cure as measured by measured by length of healthy nail of at least 5 mm
Description
Cure measured by length of healthy nail of at least 5 mm
Time Frame
24-30 weeks
Title
Nail cure as measured by culture and smear
Description
Nail culture and smear
Time Frame
24-30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.
Exclusion Criteria:
lunula infected with onychomycosis.
Pregnant or breast feeding female.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ofer Mazor
Phone
972-52-8566789
Email
ofmazor@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Shemer, MD
Organizational Affiliation
Dermatology Clinic Natanya Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lev Yasmin Clinic
City
Natanya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avner Shemer, MD
Phone
972-9-8655533
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
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