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
Recruitment status was Recruiting
Sponsor:
Nomir Medical Technologies
Information provided by:
Nomir Medical Technologies
ClinicalTrials.gov Identifier:
NCT00771732
First received: July 7, 2008
Last updated: October 10, 2008
Last verified: October 2008
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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
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 May 21, 2013