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Treating Onychomychosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776464
First Posted: October 21, 2008
Last Update Posted: October 21, 2008
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.
Information provided by:
Nomir Medical Technologies
  Purpose
A study to treat 4 toes at a time to eliminate Onychomycosis

Condition Intervention Phase
Onychomycosis Device: Noveon laser Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Nomir Medical Technologies:

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

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Noveon laser
    Two wavelenghts of light
  Eligibility

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

Locations
United States, Massachusetts
Nomir Medical Not yet recruiting
Waltham, Massachusetts, United States, 02452
Contact: Alan robbins, MD    781-893-1000    alanrobbins@comcast.com   
Sponsors and Collaborators
Nomir Medical Technologies
  More Information

Responsible Party: nomir medical, Nomir Medical Technologies
ClinicalTrials.gov Identifier: NCT00776464     History of Changes
Other Study ID Numbers: #10-001
First Submitted: October 18, 2008
First Posted: October 21, 2008
Last Update Posted: October 21, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases