Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585338
First received: December 18, 2007
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.

It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.

The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.


Condition Intervention Phase
Vascular Lesion
Device: Tandem 532/1064 nm Laser
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Laser treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser


Enrollment: 1
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tandem 532/1064 nm Laser
Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser
Device: Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Other Name: Treatment of Vascular Lesions

Detailed Description:

The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.

The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult age 18 years and older
  • Diagnosis of vascular lesion

Exclusion Criteria:

  • Age <18
  • Pregnancy
  • History of cutaneous photosensitivity
  • Any therapy to the proposed treatment sites within the previous two months
  • Current participation in any other investigational drug or device evaluation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585338

Locations
United States, California
Beckman Laser Institute Medical and Surgical Clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Study Director: John S Nelson, M.D, PhD Beckman Laser Institute University of California Irvine
Principal Investigator: Wangcun Jia, PhD Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen Kelly, M.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Wangcun Jia, PhD., Research Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585338     History of Changes
Other Study ID Numbers: NIH-LAMMP-ASLMS-2003-3086
Study First Received: December 18, 2007
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
facial telangiectasia,
leg vein telangiectasia
Port Wine Stain birthmarks

ClinicalTrials.gov processed this record on September 03, 2015