- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969397
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.
The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 16 years of age and older
- Have PWS suitable for comparison testing as determined by the study doctor
Exclusion Criteria:
- Less than 16 years old
- Are pregnant
- Have skin cancer
- Currently taking immunosuppressive or steroids or photosensitizing drugs
- Current participation in any other investigational drug evaluation
- Concurrent use of known photosensitizing drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulsed Dye Laser
|
Pulsed Dye Laser
|
Experimental: Topical Antiangiogenic
Topical Antiangiogenic Agents
|
Topical Antiangiogenic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improve PWS lesion blanching.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John S Nelson, M.D,PhD, Beckman Laser Institute University of California Irvine
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
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Congenital Abnormalities
- Skin Abnormalities
- Hemangioma
- Neoplasms, Vascular Tissue
- Hemangioma, Capillary
- Port-Wine Stain
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Angiogenesis Inhibitors
Other Study ID Numbers
- 20097069
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
-
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
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