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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University
ClinicalTrials.gov Identifier:
NCT01666002
First received: August 10, 2012
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Onychomycosis
Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proximal Clearance of Fungus on Nail [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
  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.
Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
No Intervention: Placebo
  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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666002

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jean Tang, MD, PhD Stanford University
Study Chair: Tyler Hollmig, MD Stanford University
Study Director: Michael Henderson, BA Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Jean Yuh Tang, Assistant Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT01666002     History of Changes
Other Study ID Numbers: Onycho-2012 
Study First Received: August 10, 2012
Results First Received: December 16, 2014
Last Updated: April 21, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016