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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Terminated (Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled)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
Information provided by (Responsible Party):
Cambridge Health Alliance

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.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenails Device: PinPointe Foot Laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Number of Participants With Adverse Events During and Following Each Study Treatment [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01920178

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United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
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Principal Investigator: Paul M Heffernan, D.P.M. Cambridge Health Alliance
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Responsible Party: Cambridge Health Alliance Identifier: NCT01920178    
Other Study ID Numbers: 0860/08/11
First Posted: August 9, 2013    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Nail Diseases
Skin Diseases