OnychomycosisPhase 2/3NCT00776464
Treating Onychomychosis
A Phase 2/3 study testing Noveon laser in people with Onychomycosis, run by Nomir Medical Technologies at 1 site in United States.
Trial summary
A study to treat 4 toes at a time to eliminate Onychomycosis Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Noveon laser
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2010
- Phase
- Phase 2/3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older
- positive onychomycosis
- negative pregnancy
Who cannot join
- peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Nomir Medical
Waltham, Massachusetts, 02452
Alan robbins, MD, 781-893-1000, alanrobbins@comcast.com
About this study
A study to treat 4 toes at a time to eliminate Onychomycosis
- Conditions
- Onychomycosis
- Being tested
- Noveon laser
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noveon laserDevice
Two wavelenghts of light
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete or near complete disappearance of toenail fungus
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009 (estimated)
- Study completionJan 2010 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nomir Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776464
- Sponsor's protocol ID
- #10-001
- Status last verified
- Oct 2008
- First submitted
- 18 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Onychomychosis
- ClinicalTrials.gov ID
- NCT00776464
- Acronym / sponsor ID
- #10-001
- Conditions
- Onychomycosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nomir Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 21 Oct 2008 (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.
A study to treat 4 toes at a time to eliminate Onychomycosis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years or older
- positive onychomycosis
- negative pregnancy
Key exclusion criteria (1 listed)
- peripheral neuropathy
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 |
|---|---|---|
| Noveon laserTwo wavelenghts of light | Device | – |
Primary outcome
Complete or near complete disappearance of toenail fungus
Time frame: 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Noveon laser in people with Onychomycosis, run by Nomir Medical Technologies at 1 site in United States.
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 1 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 21 Oct 2008. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Alan Robbins, MD (781-893-1000, alanhrobbins@comcast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete or near complete disappearance of toenail fungus (time frame: 360 days). 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 21 Oct 2008.