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.

Study Overview

• Status: Completed
• Conditions: Vascular Lesion
• Intervention / Treatment: Device: Tandem 532/1064 nm Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Beckman Laser Institute Medical and Surgical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Treatment of Vascular Lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser treatment	Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser	6 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Beckman Laser Institute University of California Irvine
• Investigators: Principal Investigator: Wangcun Jia, PhD, Beckman Laser Institute University of California Irvine; Study Director: John S Nelson, M.D, PhD, Beckman Laser Institute University of California Irvine; Principal Investigator: Kristen Kelly, M.D, Beckman Laser Institute University of California Irvine

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): January 3, 2008

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: facial telangiectasia,; leg vein telangiectasia; Port Wine Stain birthmarks
• Other Study ID Numbers: 20033086