Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Phase 1

Withdrawn

• Conditions: Port Wine Stain
• Interventions: Procedure: laser treatment of port wine stain birthmarks

• Registration Number: NCT00580944
• Lead Sponsor: University of California, Irvine

Brief Summary

Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks.

Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.

Detailed Description

The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Port Wine Stain suitable for comparison testing
• Age > 12 years and older
• minor will be accompanied by parents or guardians during laser treatment
• Apparent good health as documented by medical history

Exclusion Criteria

• History of photodermatoses or skin cancer
• Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
• Current participation in any other investigational drug or device evaluation
• Concurrent use of known photosensitizing drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Port Wien Stain Birthmark	laser treatment of port wine stain birthmarks	Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

Primary Outcome Measures

Name	Time	Method
Port Wine Stain Birthmarks blanching	8 weeks	Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume