Diode Laser Treatment of Onychomycosis

October 27, 2020 updated by: ConBio, a Cynosure Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Shoreline Foot and Ankle Center
      • Westbrook, Connecticut, United States, 06498
        • Shoreline Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diode Laser Treatment
Device: Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Other Names:
  • V-Raser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConBio, a Cynosure Company

Investigators

  • Principal Investigator: Darren Courtright, DPM, Shoreline Foot and Ankle Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4-11-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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