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

NCT01920178 | Terminated Results

• 1 other identifier: 0860/08/11
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenails

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

  12 months

Other Outcomes (1)

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

  12 months

Study Arms (2)

PinPointe Foot Laser

ACTIVE COMPARATOR

Active laser

Device: PinPointe Foot Laser

Sham laser group

SHAM COMPARATOR

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

Device: PinPointe Foot Laser

Interventions

PinPointe Foot Laser DEVICE

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

PinPointe Foot Laser; Sham laser group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (7)

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

  PMID: 14571066 BACKGROUND

• 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.

  PMID: 9104548 BACKGROUND

• 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.

  PMID: 11051136 BACKGROUND

• 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.

  PMID: 9919897 BACKGROUND

• 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.

  PMID: 11266494 BACKGROUND

• 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.

  PMID: 17373090 BACKGROUND

• 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.

  PMID: 17307276 BACKGROUND

Limitations and 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.

Results Point of Contact

• Title: Paul M. Heffernan, D.P.M.
• Organization: Cambridge Health Alliance

pheffernan@challiance.org

617-665-2556

Study Officials

• Paul M Heffernan, D.P.M.

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)