PinPointe FootLaser for the Treatment of Onychomycosis

Phase 2

Completed

• Conditions: Infected Toenails; Onychomycosis
• Interventions: Device: PinPointe FootLaser

• Registration Number: NCT00935649
• Lead Sponsor: PathoLase, Inc.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-09
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2013-04-08
• Results First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Results First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Randomized great toe	PinPointe FootLaser	Subjects with both great toes infected. Right/left randomized to treatment / no treatment

Primary Outcome Measures

Name	Time	Method
Nail Bed Clearing	48 weeks	Change in amount of clear nail over time.

Secondary Outcome Measures

Name	Time	Method
Mycology	48 weeks	KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.

Trial Locations

Locations (4)

Rochester Laser Center; 🇺🇸 Rochester, New York, United States

Dermatology Associates; 🇺🇸 Seattle, Washington, United States

Mediprobe Research Inc; 🇨🇦 London, Ontario, Canada

Endeavor Clinical Trials, PA; 🇺🇸 San Antonio, Texas, United States