Using Light Therapy to Treat Toe Nail Fungus

This study is currently recruiting participants.

Verified by Nomir Medical Technologies, October 2008

Sponsored by:	Nomir Medical Technologies
Information provided by:	Nomir Medical Technologies
ClinicalTrials.gov Identifier:	NCT00771732

Purpose

To see if four sessions of light therapy successfully treats nail fungus.

Condition	Intervention	Phase
Onychomycosis	Device: light therapy	Phase II

MedlinePlus related topics: Molds

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study

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
1: Experimental Light therapy	Device: light therapy 6 minute light therapy
2: Sham Comparator 6 minute "session" given with machine "off"	Device: light therapy combination of wavelengths

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

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

Keywords provided by Nomir Medical Technologies:

toe nail fungus

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis

Skin Diseases
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Nail Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009