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

Study Overview
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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.

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.

Official Title
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A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Conditions
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Fungal Nail Infection

Intervention / Treatment
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* Device: Laser treatment


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laser treatment<br>Laser treatment to Improve the Appearance of Onychomycosis | Device: Laser treatment<br>* Laser treatment to Improve the Appearance of Onychomycosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving the Appearance of fungal nail | Laser treatment to Improve the Appearance of Onychomycosis | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fungal nail