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Using Light Therapy to Treat Toe Nail Fungus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771732
Recruitment Status : Unknown
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was:  Recruiting
First Posted : October 13, 2008
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
Nomir Medical Technologies

Study Description
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Brief Summary:
To see if four sessions of light therapy successfully treats nail fungus.

Condition or disease Intervention/treatment Phase
Onychomycosis Device: light therapy Phase 2

Detailed Description:
This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
Study Start Date : May 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Light therapy
 Device: light therapy
6 minute light therapy
Other Name: laser threapy
Sham Comparator: 2
6 minute "session" given with machine "off"
 Device: light therapy
combination of wavelengths
Other Name: No therapy/machine is "off"


Outcome Measures
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Primary Outcome Measures :
  1. clinical improvement [ Time Frame: six months ]

Secondary Outcome Measures :
  1. mycological negative [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not on systemic anti-fungal medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771732


Contacts
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Contact: Mary E Oster 781-893-1000 m.oster@nomirmedical.com
Contact: Alan Robbins, M.D. 781-893-1000 alanhrobbins@comcast.com

Locations
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United States, Massachusetts
Paula Angelini, DPM Recruiting
Southborough, Massachusetts, United States, 02452
Contact: Paula Angelini, DPM    617-901-6421    Paula.Angelini@southboromedicalgroup.com   
Contact: Mary Oster    508-524-4632    m.oster@nomirmedical.com   
Sponsors and Collaborators
Nomir Medical Technologies
Investigators
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Study Chair: Alan Robbins, M.D. Nomir Medical Technologies
More Information
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Responsible Party: Nomir Medical Technologies
ClinicalTrials.gov Identifier: NCT00771732    
Other Study ID Numbers: 09.002
07-301
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Keywords provided by Nomir Medical Technologies:
toe nail fungus
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases