Trial record 7 of 23 for:    Open Studies | "Nail Diseases"

Using Light Therapy to Treat Toe Nail Fungus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nomir Medical Technologies
ClinicalTrials.gov Identifier:
NCT00771732
First received: July 7, 2008
Last updated: October 10, 2008
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mycological negative [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nomir Medical Technologies
ClinicalTrials.gov Identifier: NCT00771732     History of Changes
Other Study ID Numbers: 09.002, 07-301
Study First Received: July 7, 2008
Last Updated: October 10, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014