Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

Telangiectasis Clinical Trial

Official title:

Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02090517
• Other study ID #: 430519
• Secondary ID: 430519
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2013
• Last updated: June 27, 2017
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telangiectasis

Intervention

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.
• 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.
• 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.

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.

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of Cosmetic Improvement	Percent perceived improvement for nasal vessels by the patient via questionnaire.	3 months

External Links

•   University of California-Davis Department of Dermatology Clinical Research