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

NCT ID: NCT00573729

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-01-31

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.

Conditions

Port Wine Stains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulsed Dye Laser 577 nm

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

Group Type: EXPERIMENTAL

Pulsed Dye Laser 577 nm

Intervention Type: OTHER

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

Pulsed Dye Laser 595 nm

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

Group Type: EXPERIMENTAL

Pulsed Dye Laser 595 nm

Intervention Type: OTHER

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

Interventions

Pulsed Dye Laser 577 nm

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

Intervention Type: OTHER

Pulsed Dye Laser 595 nm

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

Intervention Type: OTHER

Other Intervention Names

Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks; Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

Beckman Laser Institute,University of California,Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

20065401

Identifier Type: -

Identifier Source: org_study_id