- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580944
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Port Wien Stain Birthmark
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
|
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Port Wine Stain Birthmarks blanching
Time Frame: 8 weeks
|
Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: JOHN S NELSON, M.D,Ph.D, Beckman Laser Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20064992
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Port Wine Stain
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...CompletedPort-wine StainChina
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort-wine StainUnited States
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPORT WINE STAINUnited States
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Completed
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Centre Hospitalier Universitaire de NiceCompletedPort-wine StainsFrance
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University of Lausanne HospitalsUnknownPort-wine Stains (PWS)
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Henry VasconezGraceway Pharmaceuticals, LLCTerminated
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainsUnited States
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Not yet recruitingPort-Wine Stain | Nevus Flammeus | Port-wine Birthmark
Clinical Trials on laser treatment of port wine stain birthmarks
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainsUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainUnited States
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPORT WINE STAINUnited States
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort-Wine StainUnited States
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University of California, IrvinePfizer; Beckman Laser Institute University of California IrvineCompletedPort Wine StainUnited States
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The Metis FoundationUnited States Army Institute of Surgical ResearchCompletedHypertrophic ScarUnited States
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Hospital Clinic of BarcelonaCompleted
-
University of Sao PauloRecruiting
-
The S.N. Fyodorov Eye Microsurgery State InstitutionUnknownRhegmatogenous Retinal DetachmentRussian Federation
-
GlaxoSmithKlineCompleted