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Treating Onychomychosis

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: NCT00776464
Recruitment Status : Unknown
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Nomir Medical Technologies

Study Description
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Brief Summary:
A study to treat 4 toes at a time to eliminate Onychomycosis

Condition or disease Intervention/treatment Phase
Onychomycosis Device: Noveon laser Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : January 2010
Arms and Interventions
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Intervention Details:
  • Device: Noveon laser
    Two wavelenghts of light

Outcome Measures
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Primary Outcome Measures :
  1. Complete or near complete disappearance of toenail fungus [ Time Frame: 360 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • positive onychomycosis
  • negative pregnancy

Exclusion Criteria:

  • peripheral neuropathy
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): NCT00776464


Contacts
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Contact: Alan Robbins, MD 781-893-1000 alanhrobbins@comcast.com

Locations
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United States, Massachusetts
Nomir Medical
Waltham, Massachusetts, United States, 02452
Contact: Alan robbins, MD    781-893-1000    alanrobbins@comcast.com   
Sponsors and Collaborators
Nomir Medical Technologies
More Information
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Responsible Party: nomir medical, Nomir Medical Technologies
ClinicalTrials.gov Identifier: NCT00776464    
Other Study ID Numbers: #10-001
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases