NCT00935649

PinPointe FootLaser for the Treatment of Onychomycosis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: PathoLase, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infected Toenails
• Onychomycosis

Interventions

Type	Name	Description
DEVICE	PinPointe FootLaser	Medical laser

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-07-09
• Last updated: 2013-04-09
• Results posted: 2013-04-09

Locations

4 sites across 2 countries: United States, Canada