Infected ToenailsPhase 2/3NCT00935649
PinPointe FootLaser for the Treatment of Onychomycosis
A Phase 2/3 study testing PinPointe FootLaser in people with Infected Toenails and Onychomycosis, run by PathoLase, Inc. at 4 sites in 2 countries.
Trial summary
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infected Toenails, Onychomycosis
- What is being tested?
- PinPointe FootLaser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2009to Nov 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers of either sex,
- 18-80 years of age,
- Both great toes with clinical signs of infection.
- Positive KOH or culture test
Who cannot join
- Existing or history of cancer/skin malignancy,
- Use of oral antifungal agents in past 6 months,
- Use of topical antifungal agents in past 1 month,
- Loss of protective sensation in either foot,
- Infection involving lunula of either great toe,
- Longitudinal streaks/spikes of either great toenail,
Show all 11Show fewer
- Distal nail thickness > 2 mm of either great toe,
- Prior surgical treatment of either great toe in past 12 months,
- Participation in another medical device/pharmaceutical study,
- Condition that investigator determines makes it unsafe for subject to participate,
- Pregnancy, breastfeeding or plans to become pregnant.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Rochester Laser Center
Rochester, New York, 14617
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Dermatology Associates
Seattle, Washington, 98101
About this study
Official title: Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
Read the detailed description
The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.
- Conditions
- Infected Toenails, Onychomycosis
- Being tested
- PinPointe FootLaser
- Keywords
- Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinPointe FootLaserDevice
Medical laser
| Study group | Role | What they receive |
|---|---|---|
| Randomized great toe | Experimental | Subjects with both great toes infected. Right/left randomized to treatment / no treatment Receives: Device: PinPointe FootLaser |
| Untreated Toe | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail Bed Clearing
Change in amount of clear nail over time.
Measured: 48 weeks
Secondary outcomes (1)
Mycology
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infected ToenailsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- PathoLase, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David M Harris, PhD, Study director, PathoLase, Inc.Bernard Goffe, MD, Principal investigator, Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935649
- Sponsor's protocol ID
- CLN0001.p.A
- Status last verified
- Nov 2010
- First submitted
- 7 Jul 2009
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
- ClinicalTrials.gov ID
- NCT00935649
- Acronym / sponsor ID
- CLN0001.p.A
- Conditions
- Infected Toenails, Onychomycosis
- Keywords
- Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- PathoLase, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
Detailed description
The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized great toe | Experimental | Device: PinPointe FootLaserSubjects with both great toes infected. Right/left randomized to treatment / no treatment |
| Untreated Toe | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers of either sex,
- 18-80 years of age,
- Both great toes with clinical signs of infection.
- Positive KOH or culture test
Key exclusion criteria (11 listed)
- Existing or history of cancer/skin malignancy,
- Use of oral antifungal agents in past 6 months,
- Use of topical antifungal agents in past 1 month,
- Loss of protective sensation in either foot,
- Infection involving lunula of either great toe,
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 |
|---|---|---|
| PinPointe FootLaserMedical laser | Device | Randomized great toe |
Primary outcome
Nail Bed Clearing
Time frame: 48 weeks
Change in amount of clear nail over time.
1 secondary outcome
Mycology
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
David M Harris, PhD study director
PathoLase, Inc.
Bernard Goffe, MD principal investigator
Dermatology Associates
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PinPointe FootLaser in people with Infected Toenails and Onychomycosis, run by PathoLase, Inc. at 4 sites in 2 countries.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nail Bed Clearing (time frame: 48 weeks). 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 9 Apr 2013.