Study Stopped
Study was withdrawn because the university wanted to bill study patients for use of the laser.
Laser Therapy Versus Electrosurgery For Nasal Telangiectasias
Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Jun 2014
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJune 29, 2017
June 1, 2017
1.7 years
December 4, 2013
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
Evaluation of Cosmetic Improvement
3 months
Study Arms (5)
Pulsed Dye Laser
ACTIVE COMPARATORSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser.
Long Pulsed Alexandrite Laser
ACTIVE COMPARATORSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser.
Pulsed Dye Laser Plus Nd:YAG Laser
ACTIVE COMPARATORSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser.
Electrodesiccation
ACTIVE COMPARATORSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation.
No Treatment
NO INTERVENTIONSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment.
Interventions
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.
Alexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size.
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.
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.
Eligibility Criteria
You may qualify if:
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow up visit
- millimeter Vessel size
- Non-contiguous nasal vascular lesions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California-Davis, Department of Dermatology
Sacramento, California, 95816, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Eisen, M.D.
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
March 18, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
June 29, 2017
Record last verified: 2017-06