Diode Laser Treatment of Onychomycosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier:
NCT01452490
First received: October 11, 2011
Last updated: March 25, 2014
Last verified: March 2014
  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:


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.


Enrollment: 50
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 25, 2014
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 August 27, 2014