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

NCT00573729 | Completed Phase 1

• 1 other identifier: 20065401
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Port Wine Stains

Keywords

vascular malformation

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Study Arms (2)

Pulsed Dye Laser 577 nm

EXPERIMENTAL

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

Other: Pulsed Dye Laser 577 nm

Pulsed Dye Laser 595 nm

EXPERIMENTAL

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

Other: Pulsed Dye Laser 595 nm

Interventions

Pulsed Dye Laser 577 nm OTHER

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

Also known as: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Pulsed Dye Laser 577 nm

Pulsed Dye Laser 595 nm OTHER

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

Also known as: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Pulsed Dye Laser 595 nm

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute,University of California,Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary; Vascular Malformations

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• John S Nelson, M.D., Ph.D.

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 14, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)