PinPointe FootLaser for the Treatment of Onychomycosis

Completed · Phase 2/Phase 3

Conditions studied: Infected Toenails, Onychomycosis

In brief

To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

Key facts

Study ID

NCT00935649

Run by

PathoLase, Inc.

People needed

134

Starts

2009-06-01

Expected to finish

2010-11-01

Last updated by the study team

2013-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Volunteers of either sex,
• 18-80 years of age,
• Both great toes with clinical signs of infection.
• Positive KOH or culture test

You may not qualify if…

• 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,
• 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.

Where it is running

• Rochester Laser Center — Rochester, New York, United States
• Endeavor Clinical Trials, PA — San Antonio, Texas, United States
• Dermatology Associates — Seattle, Washington, United States
• Mediprobe Research Inc — London, Ontario, Canada

Full record on ClinicalTrials.gov

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