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| Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine Candela Corporation |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00580944 |
Purpose
Port wine stain (PWS) 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 PWS birthmarks.
Since most of the malformations occur on the face, PWS is a clinically significant problem in the majority of patients. PWS 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. PWS 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Port Wine Stain |
Procedure: alexandrite laser and pulsed dye laser |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Procedure: alexandrite laser and pulsed dye laser
ALEX/PDL laser
|
The researcher' want to determine whether the combined delivery of ALEX+PDL pulses will improve PWS therapeutic outcome in response to laser therapy. The central hypothesis of the proposed research is that the combined delivery of both ALEX+PDL pulses, as compared to either alone will increase the core intravascular PWS blood vessel temperature because of significant heat accumulation in the vessels by successive laser pulses while multiple cryogen spurts will maintain the epidermal temperature well below the damage threshold.
Port wine stains (PWS) are a congenital, progressive vascular malformation of human skin. The alexandrite (ALEX) and pulsed dye lasers (PDL) are both approved by the Food and Drug Administration (FDA) for the treatment of PWS. However, the degree of PWS blanching seen following either ALEX or PDL treatment remains variable and unpredictable.
For each subject, areas of the PWS will be treated with either ALEX or PDL alone and with the combined delivery of ALEX+PDL pulses. We expect that the areas treated with the combined delivery of ALEX+PDL pulses will have improved PWS blanching responses than the areas treated with either ALEX or PDL alone.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beckman Laser institute medical and surgical clinic | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | JOHN S NELSON, M.D,Ph.D | BECKMAN LASER INSTITUTE |
More Information
| Responsible Party: | Beckman Laser Institute ( J.Stuart Nelson,M.D.,Ph.D ) |
| Study ID Numbers: | #RR-01192:PHS-NIH |
| Study First Received: | December 18, 2007 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00580944 |
| Health Authority: | United States: Institutional Review Board |
|
Port wine stain progressive malformation of human skin |
|
Skin Diseases Nevi flammei, familial multiple Port-Wine Stain Skin Abnormalities Congenital Abnormalities |
