PinPointe FootLaser for the Treatment of Onychomycosis

This study has been completed.
Sponsor:
Information provided by:
PathoLase, Inc.
ClinicalTrials.gov Identifier:
NCT00935649
First received: July 7, 2009
Last updated: April 8, 2013
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Infected Toenails
Onychomycosis
Device: PinPointe FootLaser
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)

Further study details as provided by PathoLase, Inc.:

Primary Outcome Measures:
  • Nail Bed Clearing [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in amount of clear nail over time.


Secondary Outcome Measures:
  • Mycology [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.


Enrollment: 134
Study Start Date: June 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized great toe
Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Device: PinPointe FootLaser
Medical laser
Other Name: PinPointe FootLaser
No Intervention: Untreated Toe

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935649

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

No publications provided

Responsible Party: David M Harris, PhD, PathoLase, Inc
ClinicalTrials.gov Identifier: NCT00935649     History of Changes
Other Study ID Numbers: CLN0001.p.A
Study First Received: July 7, 2009
Results First Received: April 8, 2013
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by PathoLase, Inc.:
Toenail Fungus
PinPointe
FootLaser
Onychomycosis
Fungal nails

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014