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

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

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.

Study Overview

• Status: Terminated
• Conditions: Onychomycosis of Toenails
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Cambridge Health Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events During and Following Each Study Treatment	12 months

Collaborators and Investigators

• Sponsor: Cambridge Health Alliance
• Investigators: Principal Investigator: Paul M Heffernan, D.P.M., Cambridge Health Alliance

Publications and helpful links

General Publications

• Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A. The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52. doi: 10.1080/09546630600965004.
• Arrese JE, Pierard GE. Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. doi: 10.1159/000073086.
• Elewski BE, Scher RK, Aly R, Daniel R 3rd, Jones HE, Odom RB, Zaias N, Jacko ML. Double-blind, randomized comparison of itraconazole capsules vs. placebo in the treatment of toenail onychomycosis. Cutis. 1997 Apr;59(4):217-20.
• Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000 Oct;43(4 Suppl):S70-80. doi: 10.1067/mjd.2000.109071.
• Haneke E, Abeck D, Ring J. Safety and efficacy of intermittent therapy with itraconazole in finger- and toenail onychomycosis: a multicentre trial. Mycoses. 1998 Dec;41(11-12):521-7. doi: 10.1111/j.1439-0507.1998.tb00716.x.
• Pollak R, Billstein SA. Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations. J Am Podiatr Med Assoc. 2001 Mar;91(3):127-31. doi: 10.7547/87507315-91-3-127.
• Scher RK, Tavakkol A, Sigurgeirsson B, Hay RJ, Joseph WS, Tosti A, Fleckman P, Ghannoum M, Armstrong DG, Markinson BC, Elewski BE. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44. doi: 10.1016/j.jaad.2006.12.019. Epub 2007 Feb 16.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: 0860/08/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No