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

Phase 1

Completed

• Conditions: Vascular Lesion
• Interventions: Device: Tandem 532/1064 nm Laser

• Registration Number: NCT00585338
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-03
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tandem 532/1064 nm Laser	Tandem 532/1064 nm Laser	Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser

Primary Outcome Measures

Name	Time	Method
Laser treatment	6 months	Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Trial Locations

Locations (1)

Beckman Laser Institute Medical and Surgical Clinic; 🇺🇸 Irvine, California, United States