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

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: PDL therapy (577 nm)	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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: 30 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lesions divided into two distinct areas identified by Devon Skin Marker pen ink.	Procedure: PDL therapy (577 nm) PDL therapy (577 nm)

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

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 Medical Clinic

Investigators


Principal Investigator:	John S Nelson, M.D., Ph.D.	Beckman Laser Institute Medical Clinic

More Information

Responsible Party:	Beckman Laser Institute ( J. Stuart Nelson, M.D., Ph.D. )
Study ID Numbers:	AR-47551;PHS-NIH, P41-RR01192;NIH-LAMMP
First Received:	December 6, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00573729
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

vascular malformation

Study placed in the following topic categories:

Skin Diseases

Nevi flammei, familial multiple

Port-Wine Stain

Vascular Malformations

Skin Abnormalities

Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00573729