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Diode Laser Treatment of Onychomycosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01452490
First Posted: October 14, 2011
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
October 11, 2011
October 14, 2011
March 26, 2014
October 2011
August 2013   (Final data collection date for primary outcome measure)
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement [ Time Frame: 12 months ]
Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.
Same as current
Complete list of historical versions of study NCT01452490 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diode Laser Treatment of Onychomycosis
Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Onychomycosis
Device: Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Other Name: V-Raser
Experimental: Diode Laser Treatment
Intervention: Device: Diode Laser Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01452490
D4-11-F
No
Not Provided
Not Provided
Cynosure, Inc. ( ConBio, a Cynosure Company )
ConBio, a Cynosure Company
Not Provided
Principal Investigator: Darren Courtright, DPM Shoreline Foot and Ankle Center
Cynosure, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP