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PinPointe FootLaser for the Treatment of Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935649
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by:
PathoLase, Inc.

Study Description
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Brief Summary:
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

Condition or disease Intervention/treatment Phase
Infected Toenails Onychomycosis Device: PinPointe FootLaser Phase 2 Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
Study Start Date : June 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Randomized great toe
Subjects with both great toes infected. Right/left randomized to treatment / no treatment
 Device: PinPointe FootLaser
Medical laser
No Intervention: Untreated Toe


Outcome Measures
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Primary Outcome Measures :
  1. Nail Bed Clearing [ Time Frame: 48 weeks ]
    Change in amount of clear nail over time.


Secondary Outcome Measures :
  1. Mycology [ Time Frame: 48 weeks ]
    KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935649


Locations
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United States, New York
Rochester Laser Center
Rochester, New York, United States, 14617
United States, Texas
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Canada, Ontario
Mediprobe Research Inc
London, Ontario, Canada, N5X 2P1
Sponsors and Collaborators
PathoLase, Inc.
Investigators
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Study Director: David M Harris, PhD PathoLase, Inc.
Principal Investigator: Bernard Goffe, MD Dermatology Associates
More Information
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Responsible Party: David M Harris, PhD, PathoLase, Inc
ClinicalTrials.gov Identifier: NCT00935649    
Other Study ID Numbers: CLN0001.p.A
First Posted: July 9, 2009    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013
Last Verified: November 2010
Keywords provided by PathoLase, Inc.:
Toenail Fungus
PinPointe
FootLaser
Onychomycosis
Fungal nails
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Nail Diseases
Skin Diseases