Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis

This study is currently recruiting participants.
Verified August 2013 by Cambridge Health Alliance
Sponsor:
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT01920178
First received: August 7, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Onychomycosis of Toenails
Device: PinPointe Foot Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis

Resource links provided by NLM:


Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure clinical improvement as judged by the patient [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Demonstration of device safety by documenting all adverse events during and following each study treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PinPointe Foot Laser
Active laser
Device: 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
Sham Comparator: Sham laser group
Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
Device: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920178

Contacts
Contact: Judy Petelle 617-665-2558 jpetelle@challiance.org

Locations
United States, Massachusetts
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Judy Petelle    617-665-2558    jpetelle@challiance.org   
Principal Investigator: Paul M Heffernan, D.P.M.         
Sub-Investigator: Harry Schneider, D.P.M.         
Sponsors and Collaborators
Cambridge Health Alliance
Investigators
Principal Investigator: Paul M Heffernan, D.P.M. Cambridge Health Alliance
  More Information

Publications:

Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT01920178     History of Changes
Other Study ID Numbers: 0860/08/11
Study First Received: August 7, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014