Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585338
First received: December 18, 2007
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  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 (MCS-MLP). This mode may reduce malformed blood vessels with a low incidence of long-term side effects.

The purpose of this pilot study will be to determine if the Tandem 532/1064 nm laser can achieve blanching of vascular lesions such as facial telangiectasia, leg veins, PWS.


Condition Intervention Phase
Vascular Lesion
 Other: Treatment of Vascular Lesions With a 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

Resource links provided by NLM:

Drug Information available for: Tandem
U.S. FDA Resources

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

Primary Outcome Measures:
  • demonstrate vascular lesions blanching with no or only mild AE(hyperpigmentation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
Treatment of Vascular Lesions
Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser
 Other: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Other Name: Tandem 532/1064 nm Laser

Detailed Description:

Efficacy will be assessed by determining blanching of vascular lesions after treatment. The researcher' will be monitoring for any other adverse effects which may be associated with this laser including scarring, hypopigmentation, ulceration or an other unexpected effect.

Subjects with darker skin types will be at higher risk for adverse effects and treatment parameters will be chosen appropriately to minimize any increase in risk. This device does have cryogen spray cooling which protects the epidermis and decreases the risk of adverse effects in darker skin types.

One to four test sites will be chosen. On each site 1-10 pulses will be performed. Different laser parameters may be used for each test site. The subject will return for evaluation of the test sites at 6-12 weeks.

At the follow-up evaluation, the period of bruising will be evaluated and lesion blanching will be graded. Test areas will also be evaluated for adverse effects.

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
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
Montana Compton
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
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585338     History of Changes
Other Study ID Numbers: ASLMS-41746; SWF-43653
Study First Received: December 18, 2007
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
facial telangiectasia,
leg vein telangiectasia
PWS birthmarks

ClinicalTrials.gov processed this record on May 23, 2013