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

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ClinicalTrials.gov Identifier: NCT01920178
Recruitment Status : Terminated (Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled)
First Posted : August 9, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Cambridge Health Alliance

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE August 9, 2013
Results First Submitted Date  ICMJE July 15, 2016
Results First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Measure clinical improvement as judged by the patient [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2017)
Number of Participants With Adverse Events During and Following Each Study Treatment [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures
 (submitted: August 7, 2013)
Demonstration of device safety by documenting all adverse events during and following each study treatment [ Time Frame: 12 months ]
 
Descriptive Information
Brief Title  ICMJE Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis of Toenails
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: PinPointe Foot Laser
    Active laser
    Intervention: Device: PinPointe Foot Laser
  • Sham Comparator: Sham laser group
    Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
    Intervention: Device: PinPointe Foot Laser
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
30
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920178
Other Study ID Numbers  ICMJE 0860/08/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cambridge Health Alliance
Study Sponsor  ICMJE Cambridge Health Alliance
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul M Heffernan, D.P.M. Cambridge Health Alliance
PRS Account Cambridge Health Alliance
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP