The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7
commercially available topical antiviral drug
Over the counter topical cream used to aid the healing process in skin lesions
University of Kentucky Division of Plastic Surgery
Lexington, Kentucky, United States
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software
Time frame: 3 months
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