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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01666002
• Other study ID #: Onycho-2012
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2012
• Last updated: August 22, 2012
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2012
• Source: Stanford University
• Contact: Tyler Hollmig, MD
• Phone: 650-723-6316
• Email: onychotrial[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Epub 2007 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	The investigators will measure the number of patients experiencing adverse events (eg. pain during or post-laser therapy, rash, etc...)	1 year	Yes
Primary	Proximal clearance of fungus on nail	The investigators will measure proximal clearance of toenail (mm) at 1, 3, 6 months and 1 year.	1 year	No