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

Primary Purpose

Onychomycosis of Toenails

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PinPointe Foot Laser

About this trial

This is an interventional treatment trial for Onychomycosis of Toenails

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cambridge Health Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

PinPointe Foot Laser

Sham laser group

Arm Description

Active laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

Outcomes

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.

Secondary Outcome Measures

Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples

Full Information

NCT ID

NCT01920178

First Posted

August 7, 2013

Last Updated

April 18, 2017

Sponsor

Cambridge Health Alliance

1. Study Identification

Unique Protocol Identification Number

NCT01920178

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cambridge Health Alliance

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onychomycosis of Toenails

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PinPointe Foot Laser

Arm Type

Active Comparator

Arm Description

Active laser

Arm Title

Sham laser group

Arm Type

Sham Comparator

Arm Description

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

Intervention Type

Device

Intervention Name(s)

PinPointe Foot Laser

Intervention Description

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 Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Number of Participants With Adverse Events During and Following Each Study Treatment

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul M Heffernan, D.P.M.

Organizational Affiliation

Cambridge Health Alliance

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge Health Alliance

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14571066

Citation

Arrese JE, Pierard GE. Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. doi: 10.1159/000073086.

Results Reference

background

PubMed Identifier

9104548

Citation

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.

Results Reference

background

PubMed Identifier

11051136

Citation

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.

Results Reference

background

PubMed Identifier

9919897

Citation

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.

Results Reference

background

PubMed Identifier

11266494

Citation

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.

Results Reference

background

PubMed Identifier

17373090

Citation

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.

Results Reference

background

PubMed Identifier

17307276

Citation

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.

Results Reference

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

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