Onychomycosis
Conditions
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.
Interventions
DEVICELaser Treatment (Pulsed Nd:YAG 1064 nm Laser)
0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Clearance of Fungus on Nail | 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser | 17 |
| 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 | 10 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
Baseline characteristics
| Characteristic | Treatment | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 4 Participants | 16 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 14 | 65 years STANDARD_DEVIATION 8 | 59 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 17 participants | 10 participants | 27 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 10 |
| serious Total, serious adverse events | 0 / 17 | 0 / 10 |
Outcome results
Primary
The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. | 12 percentage of participants |
| Placebo | The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. | 10 percentage of participants |
p-value: <0.05Chi-squared
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Proximal Clearance of Fungus on Nail | 0.44 mm | Standard Deviation 1.1 |
| Placebo | Proximal Clearance of Fungus on Nail | 0.15 mm | Standard Deviation 0.7 |
p-value: <0.05t-test, 2 sided