Onychomycosis of Toenails
Conditions
Brief summary
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
Detailed description
This protocol is designed to demonstrate that the PinPointe FootLaser treatment is able to produce clinical improvement treating onychomycosis in patients who have previously taken Terbinafine and failed treatment. The duration of enrollment for each subject will be 2 years, with the expectation that this is the time period that will yield 100% reduction in the area of involved nail. Enrollment is competitive and we expect to enroll 40 patients at CHA. The medical device that is the subject of this clinical trial is the PinPointe FootLaser, manufactured by NuvoLase, Inc. It is a pulsed Nd:Yag laser device that uses a proprietary pulse train, operating at 1064nm wavelength, with 100 μsec pulses. It received pre-market Section 510(k) clearance by the FDA and subsequent clearance for the treatment of onychomycosis in 2010. Onychomycosis (OM), a fungal infection of the toes, is a major health problem around the world. It is estimated that there are more than 40 million sufferers with this condition in the USA. A recent European study showed that the prevalence of onychomycosis may be as high as 26.9%. Importantly, it is a particular problem that disproportionately affects diabetics. The main causative agent varies according to climate. Dermatophyte infections are common worldwide. Preliminary in vitro and in vivo work has demonstrated the proof of principle that the PinPointe FootLaser device can kill microorganisms, including dermatophytes and other fungi, which infect the toenail. Based on these preliminary results, this study has been designed to demonstrate the efficacy and safety of the PinPointe FootLaser for clearing toenails, including those with onychomycosis.
Interventions
DEVICEPinPointe Foot Laser
Active Laser Treatment Group will receive active Pinpointe Foot Laser beam. Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser
Sponsors
Cambridge Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Previous treatment with at least 90 days of oral Terbinafine and completed the treatment at least 1 year ago * Able to feel a Semmes-Weinstein monofilament at the tip of each toe * Must have at least 50% involvement in at least one great toenail * Must be willing and able to present for one treatment visit and two follow-up visits at 6 months and 12 months following initial treatment to photograph the nails * Must be willing to apply topical antifungal to the skin surrounding the toes on a daily basis and be willing to spray shoes with an aerosolized antifungal on a weekly basis * Must have dystrophic toenails which clinically appear to be mycotic * Age ≥ 18 years and ≤ 70 years * Willing to comply with study requirements, including regular nail debridement as indicated by the investigator * Willing to provide informed consent to participate
Exclusion criteria
* Evidence of gangrene or non-palpable dorsalis pedis and posterior tibial pulses * Capillary refill time greater than 5 seconds * Patients who are severely immunocompromised (such as in AIDS, renal transplant regimens, immunosuppressed states consequent to malignancy or agents used in rendering oncologic care, or who suffer from end stage renal disease) * Patients with documented diagnosis of psoriasis or lichen planus * Actively treating fungal nails with a topical agent during the last 90 days prior to enrollment, including tea tree oil, antifungal nail polish, Penlac, fungoid tincture, or similar over-the-counter antifungal treatments * Inability to follow treatment regimen or comply with follow-up schedules * History of malignant melanoma or any forms of skin cancers * Evidence of acute bacterial infections with or without cellulitis and/or purulence * Treatment for onychocryptosis during the last 30 days or a history of recurrent onychocryptosis of at least 3 episodes in the last 12 months in which medical care such as resection by a podiatrist/physician, or use of antibiotics was rendered * Toenail deformity associated with trauma, psoriasis or lichen planus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples | 12 months |
Other
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events During and Following Each Study Treatment | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PinPointe Foot Laser Active laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser | 5 |
| Sham Laser Group Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.
Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser | 2 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Sham Laser Group | PinPointe Foot Laser | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Continuous | 47.0 years STANDARD_DEVIATION 2.8 | 43.2 years STANDARD_DEVIATION 13.2 | 44.3 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 2 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
Primary
Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.
Time frame: 12 months
Population: Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.
Secondary
Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples
Time frame: 12 months
Population: PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.
Other Pre-specified
Number of Participants With Adverse Events During and Following Each Study Treatment
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PinPointe Foot Laser | Number of Participants With Adverse Events During and Following Each Study Treatment | 0 participants |
| Sham Laser Group | Number of Participants With Adverse Events During and Following Each Study Treatment | 0 participants |