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Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

Primary Purpose

Telangiectasis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed Dye Laser
Long Pulsed Alexandrite Laser
Pulsed Dye Laser Plus Nd:YAG Laser
Electrodesiccation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Telangiectasis focused on measuring Nasal telangiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California-Davis, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Pulsed Dye Laser

Long Pulsed Alexandrite Laser

Pulsed Dye Laser Plus Nd:YAG Laser

Electrodesiccation

No Treatment

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
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

Evaluation of Cosmetic Improvement
Percent perceived improvement for nasal vessels by the patient via questionnaire.

Full Information

First Posted
December 4, 2013
Last Updated
June 27, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02090517
Brief Title
Laser Therapy Versus Electrosurgery For Nasal Telangiectasias
Official Title
Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was withdrawn because the university wanted to bill study patients for use of the laser.
Study Start Date
June 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasis
Keywords
Nasal telangiectasis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Dye Laser
Arm Type
Active Comparator
Arm Description
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser.
Arm Title
Long Pulsed Alexandrite Laser
Arm Type
Active Comparator
Arm Description
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser.
Arm Title
Pulsed Dye Laser Plus Nd:YAG Laser
Arm Type
Active Comparator
Arm Description
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser.
Arm Title
Electrodesiccation
Arm Type
Active Comparator
Arm Description
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation.
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment.
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser
Other Intervention Name(s)
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.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Long Pulsed Alexandrite Laser
Intervention Description
Alexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size.
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser Plus Nd:YAG Laser
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrodesiccation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluation of Cosmetic Improvement
Description
Percent perceived improvement for nasal vessels by the patient via questionnaire.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research

Learn more about this trial

Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

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