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

Not Applicable

Completed

• Conditions: Onychomycosis

• Registration Number: NCT01666002
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Results First Submitted: 2014-12-16
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Results First Posted: 2016-05-30
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.	1 year

Secondary Outcome Measures

Name	Time	Method
Proximal Clearance of Fungus on Nail	1 year	The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States