Conditions: Port Wine Stains
Keywords: laser pediatric skin pigmentation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

Detailed description:
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.

Arms:
arm 1: Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. arm 2: Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.

Interventions: intervention 1: Imiquimod intervention 2: non-medicated petroleum cream
Intervention descriptions: intervention 1: commercially available topical antiviral drug intervention 2: Over the counter topical cream used to aid the healing process in skin lesions

Protocol document: