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Using Light Therapy to Treat Toe Nail Fungus

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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

Tracking Information
First Submitted Date  ICMJE July 7, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date October 13, 2008
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
clinical improvement [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
mycological negative [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Light Therapy to Treat Toe Nail Fungus
Official Title  ICMJE Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
Brief Summary To see if four sessions of light therapy successfully treats nail fungus.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Device: light therapy
    6 minute light therapy
    Other Name: laser threapy
  • Device: light therapy
    combination of wavelengths
    Other Name: No therapy/machine is "off"
Study Arms  ICMJE
  • Experimental: 1
    Light therapy
    Intervention: Device: light therapy
  • Sham Comparator: 2
    6 minute "session" given with machine "off"
    Intervention: Device: light therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • not on systemic anti-fungal medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771732
Other Study ID Numbers  ICMJE 09.002
07-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nomir Medical Technologies
Study Sponsor  ICMJE Nomir Medical Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alan Robbins, M.D. Nomir Medical Technologies
PRS Account Nomir Medical Technologies
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP