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| Descriptive Information Fields | |||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||
| Primary Outcome Measure † | Improvement in blanching for the combined ALEX+PDL therapy in comparison with ALEX alone is calculated for each subject as B(ALEX+PDL) - B(ALEX). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Port Wine Stain | ||||
| Intervention † | Procedure: alexandrite laser and pulsed dye laser | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 20 | ||||
| Start Date † | April 2007 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00580944 | ||||
| Organization ID | #RR-01192:PHS-NIH | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Beckman Laser Institute Medical Clinic Candela Corporation |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | December 18, 2007 | ||||
| Last Updated Date | May 22, 2008 | ||||