Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Primary Purpose
Port Wine Stain
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
laser treatment of port wine stain birthmarks
Sponsored by
About this trial
This is an interventional treatment trial for Port Wine Stain focused on measuring Port wine stain, progressive malformation of human skin
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Port Wien Stain Birthmark
Arm Description
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00580944
First Posted
December 18, 2007
Last Updated
October 19, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00580944
Brief Title
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Official Title
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participant enrolled
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
Port wine stain, progressive malformation of human skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Port Wien Stain Birthmark
Arm Type
Experimental
Arm Description
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
Intervention Type
Procedure
Intervention Name(s)
laser treatment of port wine stain birthmarks
Intervention Description
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
Primary Outcome Measure Information:
Title
Port Wine Stain Birthmarks blanching
Description
Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOHN S NELSON, M.D,Ph.D
Organizational Affiliation
Beckman Laser Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
We'll reach out to this number within 24 hrs