Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Stanford University

Status: Completed

Conditions: Onychomycosis

Treatments: Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Study type: Interventional

Funder types: Other

Identifiers

NCT01666002

Onycho-2012

Details and patient eligibility

About

The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

Full description

Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have Onychomycosis on at least one toe.
• Age 18 or older.
• Consent to research use of their toenail clippings.

Exclusion criteria

• Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
• Pregnant female.
• Age 75 or older.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Treatment

Experimental group

Description:

1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. 2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.

Treatment:

Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Placebo

No Intervention group

Description:

1. st visit: For the control group, no treatment will be given. 2. nd visit: 2 weeks after initial visit, patient will be seen for second visit