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

Primary Purpose

Port Wine Stains

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pulsed Dye Laser 577 nm

Pulsed Dye Laser 595 nm

About this trial

This is an interventional treatment trial for Port Wine Stains focused on measuring vascular malformation

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beckman Laser Institute,University of California,Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pulsed Dye Laser 577 nm

Pulsed Dye Laser 595 nm

Arm Description

Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks

Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks

Outcomes

Primary Outcome Measures

Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm

Secondary Outcome Measures

Full Information

NCT ID

NCT00573729

First Posted

December 6, 2007

Last Updated

October 19, 2022

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

1. Study Identification

Unique Protocol Identification Number

NCT00573729

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Port Wine Stains

Keywords

vascular malformation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pulsed Dye Laser 577 nm

Arm Type

Experimental

Arm Description

Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks

Arm Title

Pulsed Dye Laser 595 nm

Arm Type

Experimental

Arm Description

Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks

Intervention Type

Other

Intervention Name(s)

Pulsed Dye Laser 577 nm

Other Intervention Name(s)

Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Pulsed Dye Laser 595 nm

Other Intervention Name(s)

Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John S Nelson, M.D., Ph.D.

Organizational Affiliation

Beckman Laser Institute University of California Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beckman Laser Institute,University of California,Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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