thor and clinical professor of dermatopathology at Harvard Medical School in Boston, Mass. "A key problem is that port wine stain birthmarks can recur after laser therapy due to reformation of blood vessels. This pilot study set out to determine if adding a topically applied angiogenesis inhibitor that works by disrupting the body's normal wound healing response would prevent a reoccurrence."
Imiquimod is a topical immune response modifier agent that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of actinic keratoses, superficial basal cell carcinomas and genital warts. Imiquimod is also known to have anti-angiogenic (inhibits the growth of new blood vessels) properties which might prove to be very useful in preventing port wine stain blood vessel recurrence following PDL therapy. The present study represents an off-label use of Imiquimod.
Clinical Study Results
A total of 20 patients ranging in age from three to 56 with port wine stain birthmarks had three test sites placed on their lesion which were treated using the following regimens: 1) PDL plus Imiquimod; 2) PDL alone; and 3) Imiquimod alone. For the PDL plus Imiquimod and the Imiquimod alone test sites, patients were instructed to apply Imiquimod topically as a thin layer once daily for one month following therapy.
In order to objectively assess the efficacy of the fading of the port wine stain birthmarks, a dermatological measurement tool was used to calculate the hemoglobin-index (or the amount of blood in the lesions) in the three different test sites at each follow-up visit - one, three, six and 12 months following PDL therapy. The individual performing these measurements was blinded as to the test sites' treatment regimen.
Based on the amount of blood in the lesions at each follow-up visit, test sites which received the combined PDL and Imiquimod treatment regime
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