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

Port Wine Stain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580944
• Other study ID #: 20064992
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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