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

December 18, 2007
August 5, 2015
December 2007
October 2010   (final data collection date for primary outcome measure)
Laser treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
demonstrate vascular lesions blanching with no or only mild AE(hyperpigmentation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00585338 on ClinicalTrials.gov Archive Site
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Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Lesion
Device: Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Other Name: Treatment of Vascular Lesions
Experimental: Tandem 532/1064 nm Laser
Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser
Intervention: Device: Tandem 532/1064 nm Laser
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585338
NIH-LAMMP-ASLMS-2003-3086
No
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Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
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
University of California, Irvine
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP