PinPointe FootLaser for the Treatment of Onychomycosis

• 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: PathoLase, Inc.
• Information provided by: PathoLase, Inc.

Tracking Information

• First Submitted Date: July 7, 2009
• First Posted Date: July 9, 2009
• Results First Submitted Date: April 8, 2013
• Results First Posted Date: April 9, 2013
• Last Update Posted Date: April 9, 2013
• Study Start Date: June 2009
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2013)

Nail Bed Clearing [ Time Frame: 48 weeks ]

Change in amount of clear nail over time.

• Original Primary Outcome Measures (submitted: July 7, 2009): nail bed clearing [ Time Frame: One year ]

Current Secondary Outcome Measures (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 (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: PinPointe FootLaser for the Treatment of Onychomycosis
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Infected Toenails
• Onychomycosis

Intervention

Device: PinPointe FootLaser

Medical laser

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 29, 2010): 134
• Original Estimated Enrollment (submitted: July 7, 2009): 125
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00935649
• Other Study ID Numbers: CLN0001.p.A
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: David M Harris, PhD, PathoLase, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: PathoLase, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: PathoLase, Inc.
• Verification Date: November 2010