PinPointe FootLaser for the Treatment of Onychomycosis

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00935649
Study type	Interventional
Source	PathoLase, Inc.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2009
Completion date	November 2010

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See also
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