PinPointe FootLaser for the Treatment of Onychomycosis

April 8, 2013 updated by: PathoLase, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N5X 2P1
        • Mediprobe Research Inc
  • United States
    • New York
      • Rochester, New York, United States, 14617
        • Rochester Laser Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, PA
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nail Bed Clearing
Time Frame: 48 weeks
Change in amount of clear nail over time.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mycology
Time Frame: 48 weeks
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PathoLase, Inc.

Investigators

  • Study Director: David M Harris, PhD, PathoLase, Inc.
  • Principal Investigator: Bernard Goffe, MD, Dermatology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0001.p.A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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