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Completed

NCT Number: NCT00935649

PinPointe FootLaser for the Treatment of Onychomycosis

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

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Key information

Conditions

Infected Toenails Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Onychomycosis Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mediprobe Research Inc, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PinPointe FootLaser

Device

Medical laser

Primary outcomes

  1. Nail Bed Clearing

    Time frame: 48 weeks

    Change in amount of clear nail over time.

Secondary outcomes

  1. Mycology

    Time frame: 48 weeks

    KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.

Sponsors and collaborators

Lead sponsor

PathoLase, Inc.

Industry

Registry information

Official study title

Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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