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Diode Laser Treatment of Onychomycosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier:
NCT01452490
First received: October 11, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.


Condition Intervention
Onychomycosis
 Device: Diode Laser Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis

Resource links provided by NLM:

MedlinePlus related topics: Molds
U.S. FDA Resources

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.


Estimated Enrollment: 49
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diode Laser Treatment Device: Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Other Name: V-Raser

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
  • Fitzpatrick Skin Type I-IV
  • Written and verbal informed consent
  • Able to comply with study instructions and to return to the clinic for required visits
  • Agrees to refrain from other active topical, laser or light-based treatment to the great toes
  • Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis

Exclusion Criteria:

  • Pregnancy, breastfeeding or planning to become pregnant
  • History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
  • Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
  • Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
  • Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
  • Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
  • Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
  • Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
  • Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
  • Immunocompromised status, or with existing (or history of) cancer/skin malignancy
  • Distal nail thickness of greater than 2mm in the affected great toenail
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452490

Locations
United States, Connecticut
Shoreline Foot and Ankle Center
New London, Connecticut, United States, 06320
Shoreline Foot and Ankle Center
Westbrook, Connecticut, United States, 06498
Sponsors and Collaborators
ConBio, a Cynosure Company
Investigators
Principal Investigator: Darren Courtright, DPM Shoreline Foot and Ankle Center
  More Information

No publications provided

Responsible Party: Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier: NCT01452490     History of Changes
Other Study ID Numbers: D4-11-F
Study First Received: October 11, 2011
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cynosure, Inc.:
Onychomycosis
Toenail Fungus

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013