Status:
COMPLETED
PinPointe FootLaser for the Treatment of Onychomycosis
Lead Sponsor:
PathoLase, Inc.
Conditions:
Infected Toenails
Onychomycosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Volunteers of either sex,
- 18-80 years of age,
- Both great toes with clinical signs of infection.
- Positive KOH or culture test
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00935649
Start Date
June 1 2009
End Date
November 1 2010
Last Update
April 9 2013
Active Locations (4)
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1
Rochester Laser Center
Rochester, New York, United States, 14617
2
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
3
Dermatology Associates
Seattle, Washington, United States, 98101
4
Mediprobe Research Inc
London, Ontario, Canada, N5X 2P1