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):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573729
First received: December 6, 2007
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to improve port wine stain (PWS) therapeutic outcome in response to pulsed dye laser (PDL) therapy by comparison of 577 nm versus 595 nm Wavelengths.

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

PWS are a congenital, progressive vascular malformation of human skin. The pulsed dye laser (PDL) is approved by the Food and Drug Administration (FDA) for the treatment of PWS. However, the degree of PWS blanching seen following PDL 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 PDL treatments. Moreover, less than 50% of patients achieve 50% fading of their PWS in response to PDL therapy.


Condition Intervention Phase
Port Wine Stains
Procedure: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Other: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 PDL 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
laser treament
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Procedure: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Other: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Detailed Description:

In this single center pilot study, PWS subjects will have half of their PWS treated using a PDL operating at a wavelength of 577 nm. The other half of the PWS will be treated using a PDL operating at a wavelength of 595 nm. The researchers' expect that the PWS treated with the 577 nm PDL will have improved PWS blanching responses than the areas treated with 595 nm PDL. The degree of PWS blanching which will be quantified objectively using visible reflectance spectroscopy (VRS) measurements.

Subjects will be recruited from an outpatient population of subjects with PWS at the Beckman Laser Institute and Medical Clinic, University of California, Irvine. Subjects with the requisite diagnosis of PWS (previously laser-treated or untreated) will be candidates for enrollment.

In this single center pilot study, PWS subjects will have half of their PWS treated using a PDL operating at a wavelength of 577 nm. The other half of the PWS will be treated using a PDL operating at a wavelength of 595 nm.

Both PDL are FDA-approved for PWS laser treatment. Both PDL are manufactured by Candela Laser Corporation (Wayland , MA).

Post-treatment blanching responses as determined quantitatively by visual reflectance spectroscopy (VRS) will be compared with pre-treatment measurements of PWS fractional blood volume.

Further patient treatment will be dictated based on which wavelength resulted in the best therapeutic outcome in terms of PWS blanching. Subjects will be offered the opportunity to continue receiving treatment with the wavelength that produced the base clinical results.

  Eligibility

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

Inclusion Criteria:

  • PWS 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 PWS 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
Montana Compton
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: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573729     History of Changes
Other Study ID Numbers: AR-47551;PHS-NIH
Study First Received: December 6, 2007
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
vascular malformation

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

ClinicalTrials.gov processed this record on August 28, 2014