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

• Sponsor: Cambridge Health Alliance (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01920178
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Onychomycosis of Toenails	Device: PinPointe Foot Laser	N/A

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 Design

• Study Type: Interventional
• 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: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

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

Outcome Measures

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. [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 [12 months]

Other Outcome Measures

1. Number of Participants With Adverse Events During and Following Each Study Treatment [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cambridge Health Alliance	Cambridge	Massachusetts	United States	02139

Sponsors and Collaborators

• Cambridge Health Alliance

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arrese JE, Piérard GE. Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. Review.
• 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.
• 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.
• 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.
• 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.
• 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. Epub 2007 Feb 16. Review.

• Responsible Party: Cambridge Health Alliance
• ClinicalTrials.gov Identifier: NCT01920178
• Other Study ID Numbers: 0860/08/11
• First Posted: Aug 9, 2013
• Last Update Posted: May 30, 2017
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Onychomycosis

Study Results

Participant Flow

Arm/Group Title	PinPointe Foot Laser	Sham Laser Group
Arm/Group Description	Active laser 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	Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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
Period Title: Overall Study
STARTED	5	2
COMPLETED	3	1
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	PinPointe Foot Laser	Sham Laser Group	Total
Arm/Group Description	Active laser 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	Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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	Total of all reporting groups
Overall Participants	5	2	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	2 100%	7 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (13.2)	47.0 (2.8)	44.3 (11.0)
Sex: Female, Male (Count of Participants)
Female	3 60%	1 50%	4 57.1%
Male	2 40%	1 50%	3 42.9%
Region of Enrollment (participants) [Number]
United States	5 100%	2 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.

Arm/Group Title	PinPointe Foot Laser	Sham Laser Group
Arm/Group Description	Active laser 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	Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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
Measure Participants	0	0

2. Secondary Outcome

Title	Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.

Arm/Group Title	PinPointe Foot Laser	Sham Laser Group
Arm/Group Description	Active laser 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	Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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
Measure Participants	0	0

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PinPointe Foot Laser	Sham Laser Group
Arm/Group Description	Active laser 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	Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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
Measure Participants	5	2
Number [participants]	0 0%	0 0%

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	Adverse events assessed both during and following each study treatment for all 10 toes with 2 laser passes over each clinically infected nail and one laser pass over each nail with no clinical signs of onychomycosis performed at each treatment.
Arm/Group Title	PinPointe Foot Laser		Sham Laser Group
Arm/Group Description	Active laser 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		Treatment with only localizing (aiming) beam of Pinpointe Foot Laser 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
All Cause Mortality
	PinPointe Foot Laser		Sham Laser Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PinPointe Foot Laser		Sham Laser Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	PinPointe Foot Laser		Sham Laser Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/2 (0%)

Limitations/Caveats

Withdrawal of financial support by Nuvolase, Inc in June, 2014 with very small enrollment of only 7 subjects ( 40 originally anticipated) led to loss of vital Primary and Secondary Outcome Measures with no reliable or interpretable data produced.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.