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| Descriptive Information Fields | |||||
| Brief Title † | Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks | ||||
| Official Title † | Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks | ||||
| Brief Summary | Port wine stains (PWS) are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating PWS is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the PDL treatment is likely an important factor in why these lesions persist despite therapy. |
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| Detailed Description | Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research' expect that it will have similar effects on port wine stains, but this has not yet been reported. This study is to determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions. In this single center study, PWS subjects will receive treatment to their PWS with a laser in combination with epidermal cooling. The lasers to be utilized are FDA approved for treatment of PWS birthmarks and are currently used at the Beckman Laser Institute. Starting the first post-treatment day, subjects will apply one sachet per 25 cm2 of treatment area of either imiquimod 5% cream or vehicle (placebo) cream to a limited area (25 cm2) of their PWS three days each week (eg, M-W-F or T-Th-S) for 8 weeks. At each dosing period, study drug should remain in place for 8±2 hrs (preferably during normal sleeping hours) and remain unoccluded. Randomization to treatment or control group will occur after laser treatment of their PWS. Subjects in either treatment arm will therefore receive equivalent laser therapy. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Other, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Port Wine Stain | ||||
| Intervention † | Drug: topical imiquimod 5% cream | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 20 | ||||
| Start Date † | November 2006 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00585247 | ||||
| Organization ID | 3M-39936;3M | ||||
| Secondary IDs †† | graceway pharma., P41-RR01192;NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Beckman Laser Institute Medical Clinic Graceway Pharmaceuticals Sturge Weber Foundation |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | December 18, 2007 | ||||
| Last Updated Date | July 25, 2008 | ||||
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