Using Light Therapy to Treat Toe Nail Fungus

NCT ID: NCT00771732

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Onychomycosis

Keywords

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toe nail fungus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Light therapy

Group Type EXPERIMENTAL

light therapy

Intervention Type DEVICE

6 minute light therapy

2

6 minute "session" given with machine "off"

Group Type SHAM_COMPARATOR

light therapy

Intervention Type DEVICE

combination of wavelengths

Interventions

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light therapy

6 minute light therapy

Intervention Type DEVICE

light therapy

combination of wavelengths

Intervention Type DEVICE

Other Intervention Names

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laser threapy No therapy/machine is "off"

Eligibility Criteria

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Inclusion Criteria

* toe nail fungus, not infolving lunula
* between ages 18-70 years old

Exclusion Criteria

* not on systemic anti-fungal medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nomir Medical Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Nomir Medical Technologies

Principal Investigators

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Alan Robbins, M.D.

Role: STUDY_CHAIR

Nomir Medical Technologies

Locations

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Paula Angelini, DPM

Southborough, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary E Oster

Role: CONTACT

Phone: 781-893-1000

Email: [email protected]

Alan Robbins, M.D.

Role: CONTACT

Phone: 781-893-1000

Email: [email protected]

Facility Contacts

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Paula Angelini, DPM

Role: primary

Mary Oster

Role: backup

Other Identifiers

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07-301

Identifier Type: -

Identifier Source: secondary_id

09.002

Identifier Type: -

Identifier Source: org_study_id