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

NCT ID: NCT00580944

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Port Wine Stain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Port Wien Stain Birthmark

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

Group Type: EXPERIMENTAL

laser treatment of port wine stain birthmarks

Intervention Type: PROCEDURE

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

Interventions

laser treatment of port wine stain birthmarks

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• 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

Other Identifiers

20064992

Identifier Type: -

Identifier Source: org_study_id