OnychomycosisPhase 4NCT02436291
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
A Phase 4 study testing CURE-EX device in people with Onychomycosis, run by MB Mazor Ltd. at 1 site in Israel.
Trial summary
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- CURE-EX device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- lunula infected with onychomycosis.
- Pregnant or breast feeding female.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lev Yasmin Clinic
Netanya
Avner Shemer, MD, 972-9-8655533
About this study
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- CURE-EX device
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURE-EX deviceDevice
Treatment with CURE-EX device twice daily for 24-30 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CURE-EX device | Experimental | twice daily treatment with CURE-EX device for 24-30 weeks Receives: Device: CURE-EX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-30 weeks
Nail cure as measured by culture and smear
Nail culture and smear
Measured: 24-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MB Mazor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avner Shemer, MD, Principal investigator, Dermatology Clinic Natanya Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436291
- Sponsor's protocol ID
- CURE-01
- Status last verified
- Apr 2015
- First submitted
- 28 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
- ClinicalTrials.gov ID
- NCT02436291
- Acronym / sponsor ID
- CURE-01
- Conditions
- Onychomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MB Mazor Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CURE-EX device | Experimental | Device: CURE-EX devicetwice daily treatment with CURE-EX device for 24-30 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- lunula infected with onychomycosis.
- Pregnant or breast feeding female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CURE-EX deviceTreatment with CURE-EX device twice daily for 24-30 weeks. | Device | CURE-EX device |
Primary outcome
Nail cure as measured by measured by length of healthy nail of at least 5 mm
Time frame: 24-30 weeks
Cure measured by length of healthy nail of at least 5 mm
Nail cure as measured by culture and smear
Time frame: 24-30 weeks
Nail culture and smear
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avner Shemer, MD principal investigator
Dermatology Clinic Natanya Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CURE-EX device in people with Onychomycosis, run by MB Mazor Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Mazor (972-52-8566789, ofmazor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nail cure as measured by measured by length of healthy nail of at least 5 mm (time frame: 24-30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.