OnychomycosisPhase 2NCT00771732
Using Light Therapy to Treat Toe Nail Fungus
A Phase 2 study testing light therapy in people with Onychomycosis, run by Nomir Medical Technologies at 1 site in United States.
Trial summary
To see if four sessions of light therapy successfully treats nail fungus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2009
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- toe nail fungus, not infolving lunula
- between ages 18-70 years old
Who cannot join
- not on systemic anti-fungal medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Paula Angelini, DPM
Southborough, Massachusetts, 02452
Paula Angelini, DPM, 617-901-6421, Paula.Angelini@southboromedicalgroup.com
Mary Oster, 508-524-4632, m.oster@nomirmedical.com
About this study
Official title: Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
To see if four sessions of light therapy successfully treats nail fungus.
Read the detailed description
This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.
- Conditions
- Onychomycosis
- Being tested
- light therapy
- Keywords
- toe nail fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light therapyDevice
Also called laser threapy
6 minute light therapy
light therapyDevice
Also called No therapy/machine is "off"
combination of wavelengths
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Light therapy Receives: Device: light therapy |
| 2 | Sham comparator | 6 minute "session" given with machine "off" Receives: Device: light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement
Measured: six months
Secondary outcomes (1)
mycological negative
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nomir Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Robbins, M.D., Study chair, Nomir Medical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771732
- Sponsor's protocol ID
- 09.002
- Other IDs
- 07-301
- Status last verified
- Oct 2008
- First submitted
- 7 Jul 2008
- Last updated
- 13 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
- ClinicalTrials.gov ID
- NCT00771732
- Acronym / sponsor ID
- 09.002
- Conditions
- Onychomycosis
- Keywords
- toe nail fungus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nomir Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 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.
To see if four sessions of light therapy successfully treats nail fungus.
Detailed description
This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: light therapyLight therapy |
| 2 | Sham comparator | Device: light therapy6 minute "session" given with machine "off" |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- toe nail fungus, not infolving lunula
- between ages 18-70 years old
Key exclusion criteria (1 listed)
- not on systemic anti-fungal medications
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 |
|---|---|---|
| light therapyAlso: laser threapy6 minute light therapy | Device | 1 |
| light therapyAlso: No therapy/machine is "off"combination of wavelengths | Device | 2 |
Primary outcome
clinical improvement
Time frame: six months
1 secondary outcome
mycological negative
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2008.
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
Alan Robbins, M.D. study chair
Nomir Medical Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing light therapy 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 2 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 13 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mary E Oster (781-893-1000, m.oster@nomirmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement (time frame: six months). 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 13 Oct 2008.