Back to resultsUsing Light Therapy to Treat Toe Nail Fungus
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
light therapy
light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring toe nail fungus
Eligibility Criteria
Inclusion Criteria:
- toe nail fungus, not infolving lunula
- between ages 18-70 years old
Exclusion Criteria:
- not on systemic anti-fungal medications
Sites / Locations
- Paula Angelini, DPMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Light therapy
6 minute "session" given with machine "off"
Outcomes
Primary Outcome Measures
clinical improvement
Secondary Outcome Measures
mycological negative
Full Information
NCT ID
NCT00771732
First Posted
July 7, 2008
Last Updated
October 10, 2008
Sponsor
Nomir Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00771732
Brief Title
Using Light Therapy to Treat Toe Nail Fungus
Official Title
Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Nomir Medical Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
toe nail fungus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Light therapy
Arm Title
2
Arm Type
Sham Comparator
Arm Description
6 minute "session" given with machine "off"
Intervention Type
Device
Intervention Name(s)
light therapy
Other Intervention Name(s)
laser threapy
Intervention Description
6 minute light therapy
Intervention Type
Device
Intervention Name(s)
light therapy
Other Intervention Name(s)
No therapy/machine is "off"
Intervention Description
combination of wavelengths
Primary Outcome Measure Information:
Title
clinical improvement
Time Frame
six months
Secondary Outcome Measure Information:
Title
mycological negative
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
toe nail fungus, not infolving lunula
between ages 18-70 years old
Exclusion Criteria:
not on systemic anti-fungal medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary E Oster
Phone
781-893-1000
Email
m.oster@nomirmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Robbins, M.D.
Phone
781-893-1000
Email
alanhrobbins@comcast.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Robbins, M.D.
Organizational Affiliation
Nomir Medical Technologies
Official's Role
Study Chair
Facility Information:
Facility Name
Paula Angelini, DPM
City
Southborough
State/Province
Massachusetts
ZIP/Postal Code
02452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Angelini, DPM
Phone
617-901-6421
Email
Paula.Angelini@southboromedicalgroup.com
First Name & Middle Initial & Last Name & Degree
Mary Oster
Phone
508-524-4632
Email
m.oster@nomirmedical.com
12. IPD Sharing Statement
Learn more about this trial
Using Light Therapy to Treat Toe Nail Fungus
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