Clincosm LogoSign in Get a demo

Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

Sponsor
University of California, Davis (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02090517
Collaborator
(none)
0
Enrollment
1
Location
5
Arms
20
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed Dye Laser
  • Device: Long Pulsed Alexandrite Laser
  • Device: Pulsed Dye Laser Plus Nd:YAG Laser
  • Procedure: Electrodesiccation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pulsed Dye Laser

Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser.

Device: Pulsed Dye Laser
Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.
Other Names:
  • Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.

    		•
    Active Comparator: Long Pulsed Alexandrite Laser

    Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser.

    Device: Long Pulsed Alexandrite Laser
    Alexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size.
    Active Comparator: Pulsed Dye Laser Plus Nd:YAG Laser

    Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser.

    Device: Pulsed Dye Laser Plus Nd:YAG Laser
    The Cynergy with MultiPlex will be used with a multiplex mode system with a pulse dye laser at 585 nanometer wavelength, 20 milliseconds pulse duration, at 7 Joules/cm2 with a 7 millimeter spot size, with a short delay, followed by a Nd:YAG 1064 nanometer wavelength, 20 millisecond pulse duration, at 50 Joules/cm2 with a 7 millimeter spot size.
    Active Comparator: Electrodesiccation

    Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation.

    Procedure: Electrodesiccation
    A curette is used to scrape off the cancer down to the dermis. The scraping is then paused while an electrosurgical device like a hyfrecator is used next. Electrodesiccation is performed over the raw surgical ulcer to denature a layer of the dermis and the curette is used again over the surgical ulcer to remove denatured dermis down to living tissue.
    No Intervention: No Treatment

    Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery [3 months]

      The study will measure the changes in length and width (area) of nasal telangiectasias before and after treatment with the following: no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.

    Secondary Outcome Measures

    1. Evaluation of Cosmetic Improvement [3 months]

      Percent perceived improvement for nasal vessels by the patient via questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Over 18 years of age

    • Able to give informed consent themselves

    • Willing to return for follow up visit

    • 0.5 - 3 millimeter Vessel size

    • 5 Non-contiguous nasal vascular lesions

    Exclusion Criteria:

    • Mentally handicapped

    • Unable to understand written and oral English

    • Incarceration

    • Under 18 years of age

    • Unwilling to return for follow up

    • Pregnant Women

    • Vessels less than 0.5 millimeter caliber

    • Less than 5 non-contiguous vessels

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California-Davis, Department of Dermatology Sacramento California United States 95816

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Daniel Eisen, M.D., University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT02090517
    Other Study ID Numbers:
    • 430519
    • 430519
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Jun 29, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by University of California, Davis
    Nasal telangiectasis
    Additional relevant MeSH terms:
    Telangiectasis

    Study Results

    No Results Posted as of Jun 29, 2017