Using Light Therapy to Treat Toe Nail Fungus

October 10, 2008 updated by: Nomir Medical Technologies

Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study

To see if four sessions of light therapy successfully treats nail fungus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • toe nail fungus, not infolving lunula
  • between ages 18-70 years old

Exclusion Criteria:

  • not on systemic anti-fungal medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Light therapy
Device: light therapy
6 minute light therapy
Other Names:
  • laser threapy
Device: light therapy
combination of wavelengths
Other Names:
  • No therapy/machine is "off"
Sham Comparator: 2
6 minute "session" given with machine "off"
Device: light therapy
6 minute light therapy
Other Names:
  • laser threapy
Device: light therapy
combination of wavelengths
Other Names:
  • No therapy/machine is "off"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical improvement
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
mycological negative
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nomir Medical Technologies

Investigators

  • Study Chair: Alan Robbins, M.D., Nomir Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 10, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.002
  • 07-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Onychomycosis

Clinical Trials on light therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe