Overview

This trial is active, not recruiting.

Condition telangiectasis
Treatments pulsed dye laser, long pulsed alexandrite laser, pulsed dye laser plus nd:yag laser, electrodesiccation
Sponsor University of California, Davis
Start date March 2013
End date March 2016
Trial size 30 participants
Trial identifier NCT02090517, 430519

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser.
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.
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)
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser.
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)
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser.
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)
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation.
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)
Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment.

Primary Outcomes

Measure
Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
time frame: 3 months

Secondary Outcomes

Measure
Evaluation of Cosmetic Improvement
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
Principal investigator Daniel Eisen, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.