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NCT00771732 Clinical Trial

Using Light Therapy to Treat Toe Nail Fungus

Onychomycosis Clinical Trial

Official title:
Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00771732
Other study ID # 09.002
Secondary ID 07-301
Status Recruiting
Phase Phase 2
First received July 7, 2008
Last updated October 10, 2008
Start date May 2008
Est. completion date December 2009

Study information
Verified date October 2008
Source Nomir Medical Technologies
Contact Mary E Oster
Phone 781-893-1000
Email m.oster@nomirmedical.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- toe nail fungus, not infolving lunula

- between ages 18-70 years old

Exclusion Criteria:

- not on systemic anti-fungal medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• light therapy
6 minute light therapy
• light therapy
combination of wavelengths

Locations
Country Name City State
United States Paula Angelini, DPM Southborough Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Nomir Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical improvement six months Yes
Secondary mycological negative 6 months No
See also
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