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

NCT ID: NCT01666002

Last Updated: 2016-05-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Intervention Type DEVICE

0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jean Yuh Tang

Assistant Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Tyler Hollmig, MD

Role: STUDY_CHAIR

Stanford University

Michael Henderson, BA

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21250792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17902014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22461276 (View on PubMed)

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.

Reference Type RESULT
PMID: 22453588 (View on PubMed)

Other Identifiers

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Onycho-2012

Identifier Type: -

Identifier Source: org_study_id