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Completed

NCT Number: NCT01666002

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

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Device

0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Proximal Clearance of Fungus on Nail

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2012
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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