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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Placebo

Arm Description

st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proximal Clearance of Fungus on Nail
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.

Full Information

First Posted
August 10, 2012
Last Updated
April 21, 2016
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01666002
Brief Title
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Official Title
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. 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.
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
st visit: For the control group, no treatment will be given. nd visit: 2 weeks after initial visit, patient will be seen for second visit
Intervention Type
Device
Intervention Name(s)
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
Intervention Description
0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Primary Outcome Measure Information:
Title
The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proximal Clearance of Fungus on Nail
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Tang, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tyler Hollmig, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Henderson, BA
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21250792
Citation
Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.
Results Reference
background
PubMed Identifier
17902014
Citation
Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008 Oct;23(4):349-53. doi: 10.1007/s10103-007-0492-4. Epub 2007 Sep 28.
Results Reference
background
PubMed Identifier
22461276
Citation
Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012 Mar-Apr;102(2):169-71. doi: 10.7547/1020169.
Results Reference
background
PubMed Identifier
22453588
Citation
Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.
Results Reference
result

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

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