Laser Therapy Versus Electrosurgery For Nasal Telangiectasias

NCT ID: NCT02090517

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Telangiectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulsed Dye Laser

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

Group Type ACTIVE_COMPARATOR

Pulsed Dye Laser

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Long Pulsed Alexandrite Laser

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Pulsed Dye Laser Plus Nd:YAG Laser

Intervention Type DEVICE

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.

Electrodesiccation

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

Group Type ACTIVE_COMPARATOR

Electrodesiccation

Intervention Type PROCEDURE

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 Treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California-Davis, Department of Dermatology

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

430519

Identifier Type: OTHER

Identifier Source: secondary_id

430519

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The BRILLIANT Study
NCT00618514 TERMINATED NA