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Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis

NCT01920178 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-05-30

Study results available
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Summary

The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.

Conditions

  • Onychomycosis of Toenails

Interventions

DEVICE

PinPointe Foot Laser

Active Laser Treatment Group will receive active Pinpointe Foot Laser beam. Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Sponsors & Collaborators

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Paul M Heffernan, D.P.M. · Cambridge Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920178 on ClinicalTrials.gov