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

December 6, 2007
August 5, 2015
March 2007
January 2009   (final data collection date for primary outcome measure)
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 ]
Improvement in blanching for the 577 nm PDL therapy in comparison with 595 nm [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00573729 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Port Wine Stains
  • 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
  • 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
  • Experimental: Pulsed Dye Laser 577 nm
    Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks
    Intervention: Other: Pulsed Dye Laser 577 nm
  • Experimental: Pulsed Dye Laser 595 nm
    Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks
    Intervention: Other: Pulsed Dye Laser 595 nm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573729
NIH-LAMMP-2006-5401
No
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: John S Nelson, M.D., Ph.D. Beckman Laser Institute University of California Irvine
University of California, Irvine
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP