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

NCT00580944 | Withdrawn Phase 1

• 1 other identifier: 20064992
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Port Wine Stain

Keywords

Port wine stain; progressive malformation of human skin

Outcome Measures

Primary Outcomes (1)

• Port Wine Stain Birthmarks blanching

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

  8 weeks

Study Arms (1)

Port Wien Stain Birthmark

EXPERIMENTAL

Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

Procedure: laser treatment of port wine stain birthmarks

Interventions

laser treatment of port wine stain birthmarks PROCEDURE

Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

Port Wien Stain Birthmark

Eligibility Criteria

• Age: 12 Years+
• 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 \> 12 years and older
• minor will be accompanied by parents or guardians during laser treatment
• Apparent good health as documented by medical history

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
• Current participation in any other investigational drug or device evaluation
• Concurrent use of known photosensitizing drugs

Sponsors & Collaborators

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

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• JOHN S NELSON, M.D,Ph.D

  Beckman Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• 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 18, 2007
• First Posted: December 27, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 20, 2022

Record last verified: 2022-10