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| Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine Graceway Pharmaceuticals, LLC Sturge-Weber Foundation |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00585247 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Port Wine Stain |
Drug: topical imiquimod 5% cream |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: topical imiquimod 5% cream
one sachet per 25 cm2 of treatment area
|
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 everyday 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.
Eligibility| 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 Cilnic | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Kristen M Kelly, M.D | Beckman Laser Institute University of California Irvine |
More Information
| Responsible Party: | Beckman Laseer Institute ( Kristen Kelly, M.D ) |
| Study ID Numbers: | 3M-39936;3M, graceway pharma., P41-RR01192;NIH-LAMMP |
| Study First Received: | December 18, 2007 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00585247 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
birthmarks |
|
Immunologic Factors Skin Diseases Nevi Flammei, Familial Multiple Port-Wine Stain Interferons |
Adjuvants, Immunologic Skin Abnormalities Imiquimod Congenital Abnormalities Acetaminophen |
|
Interferon Inducers Immunologic Factors Skin Diseases Antineoplastic Agents Therapeutic Uses Port-Wine Stain |
Physiological Effects of Drugs Adjuvants, Immunologic Skin Abnormalities Imiquimod Congenital Abnormalities Pharmacologic Actions |
