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

October 19, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute,University of California,Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: John S Nelson, M.D., Ph.D., Beckman Laser Institute University of California Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20065401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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