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Using Light Therapy to Treat Toe Nail Fungus

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:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771732
First Posted: October 13, 2008
Last Update Posted: October 13, 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
To see if four sessions of light therapy successfully treats nail fungus.

Condition Intervention Phase
Onychomycosis Device: light therapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nomir Medical Technologies:

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

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

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
Contact: Mary E Oster 781-893-1000 m.oster@nomirmedical.com
Contact: Alan Robbins, M.D. 781-893-1000 alanhrobbins@comcast.com

Locations
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
Study Chair: Alan Robbins, M.D. Nomir Medical Technologies
  More Information

Responsible Party: Nomir Medical Technologies
ClinicalTrials.gov Identifier: NCT00771732     History of Changes
Other Study ID Numbers: 09.002
07-301
First Submitted: July 7, 2008
First Posted: October 13, 2008
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by Nomir Medical Technologies:
toe nail fungus

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