Infected Toenails, Onychomycosis
Conditions
Keywords
Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails
Brief summary
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
Detailed description
The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.
Interventions
DEVICEPinPointe FootLaser
Medical laser
Sponsors
PathoLase, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Volunteers of either sex, * 18-80 years of age, * Both great toes with clinical signs of infection. * Positive KOH or culture test
Exclusion criteria
* Existing or history of cancer/skin malignancy, * Use of oral antifungal agents in past 6 months, * Use of topical antifungal agents in past 1 month, * Loss of protective sensation in either foot, * Infection involving lunula of either great toe, * Longitudinal streaks/spikes of either great toenail, * Distal nail thickness \> 2 mm of either great toe, * Prior surgical treatment of either great toe in past 12 months, * Participation in another medical device/pharmaceutical study, * Condition that investigator determines makes it unsafe for subject to participate, * Pregnancy, breastfeeding or plans to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nail Bed Clearing | 48 weeks | Change in amount of clear nail over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycology | 48 weeks | KOH, PCR and cultures of patients who were bilaterally positive or negative for each test. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Great Toe Subjects with both great toes infected. Right/left randomized to treatment / no treatment | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | Randomized Great Toe |
|---|---|
| Age Continuous | 52.1 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 139 | 0 / 0 |
| serious Total, serious adverse events | 0 / 139 | 0 / 0 |
Outcome results
Primary
Nail Bed Clearing
Change in amount of clear nail over time.
Time frame: 48 weeks
Population: There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.
Secondary
Mycology
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Time frame: 48 weeks
Population: There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.