1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

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Detailed Description

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Toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of Americans. Onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. Current treatment options have relatively limited long-term success and recurrence is common.

The researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.

Conditions

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Fungal Nail Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser treatment

Laser treatment to Improve the Appearance of Onychomycosis

Group Type OTHER

Laser treatment

Intervention Type DEVICE

Laser treatment to Improve the Appearance of Onychomycosis

Interventions

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Laser treatment

Laser treatment to Improve the Appearance of Onychomycosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult Male/ female has been diagnose with fungal nail infection on both great toenails.

Exclusion Criteria

* Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
* Excessively thick or hypertrophic nails.
* Subjects with diabetes.
* Subjects that are pregnant
* Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
* Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
* Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
* History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No