Ignite Creation Date:
2024-05-05 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00580944
Status:
WITHDRAWN
Last Update Posted:
2022-10-20
First Post:
2007-12-18
Brief Title:
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participant enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 live births Approximately 1200000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None