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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
|
| Placebo | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Treatment (Pulsed Nd:YAG 1064 nm Laser) | Device | 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Tang, MD, PhD | Stanford University | Principal Investigator |
| Tyler Hollmig, MD | Stanford University | Study Chair |
| Michael Henderson, BA | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21250792 | Background | 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. | |
| 17902014 | Background | 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. |
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Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.
We enrolled adults (18-75 years) with a clinical diagnosis of onychomycosis from the dermatology clinic at Stanford between July and December 2011. The key inclusion criterion was a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment |
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser 42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture. |
| FG001 | Placebo |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sample size calculations (STATA 10, Stat Corp, College Station, TX) indicated that we needed to enroll 24 patients at a 2:1 ratio for 80% power to detect a minimal proximal nail plate difference of 2.5 mm in the 2 groups with a 2-sided alpha of 0.05.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment |
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. | Posted | Number | percentage of participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment |
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser No patients reported complications or adverse events after 2 sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Tang MD PhD, assistant professor | Stanford University | 650-723-6316 | tangy@stanford.edu |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 22461276 | Background | 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. |
| 22453588 | Result | 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. |
| BG001 | Placebo |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 1 year | nails | Participants |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo |
| 0 | 10 | 0 | 10 |
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |