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

December 6, 2007
December 26, 2012
March 2007
January 2009   (final data collection date for primary outcome measure)
Improvement in blanching for the 577 nm PDL 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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Port Wine Stains
  • 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
laser treament
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Interventions:
  • Procedure: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
  • Other: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
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:

  • 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
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573729
AR-47551;PHS-NIH
No
Montana Compton, University of California, Irvine
Montana Compton
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
December 2012

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