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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.

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 9, 2009
Results First Submitted Date  ICMJE April 8, 2013
Results First Posted Date  ICMJE April 9, 2013
Last Update Posted Date April 9, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Nail Bed Clearing [ Time Frame: 48 weeks ]
Change in amount of clear nail over time.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Nail Bed Clearing [ Time Frame: One year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Mycology [ Time Frame: 48 weeks ]
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
nail plate growth [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PinPointe FootLaser for the Treatment of Onychomycosis
Official Title  ICMJE Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infected Toenails
  • Onychomycosis
Intervention  ICMJE Device: PinPointe FootLaser
Medical laser
Study Arms  ICMJE
  • Experimental: Randomized great toe
    Subjects with both great toes infected. Right/left randomized to treatment / no treatment
    Intervention: Device: PinPointe FootLaser
  • No Intervention: Untreated Toe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2010)
134
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
125
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00935649
Other Study ID Numbers  ICMJE CLN0001.p.A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M Harris, PhD, PathoLase, Inc
Study Sponsor  ICMJE PathoLase, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David M Harris, PhD PathoLase, Inc.
Principal Investigator: Bernard Goffe, MD Dermatology Associates
PRS Account PathoLase, Inc.
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP