Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

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:
NCT00573729
First received: December 6, 2007
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.


Condition Intervention Phase
Port Wine Stains
Other: Pulsed Dye Laser 577 nm
Other: Pulsed Dye Laser 595 nm
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulsed Dye Laser 577 nm
Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks
Other: Pulsed Dye Laser 577 nm
Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Other Name: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Experimental: Pulsed Dye Laser 595 nm
Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks
Other: Pulsed Dye Laser 595 nm
Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Other Name: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Detailed Description:

The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm.

The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm.

The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Port Wine Stain suitable for comparison testing
  • Age > 6 months of age; minor will be accompanied in the room by parents or guardians during laser treatment
  • Apparent good health as documented by medical history
  • Ability to understand and carry out subject instructions

Exclusion Criteria:

  • History of photodermatoses or skin cancer
  • Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
  • Inability to understand and carry out instructions
  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: NCT00573729

Locations
United States, California
Beckman Laser Institute,University of California,Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: John S Nelson, M.D., Ph.D. Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573729     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-5401
Study First Received: December 6, 2007
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
vascular malformation

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2015