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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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