Clinical Trial: The Effects of Aldara as an Adjunct to Laser Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains

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

Detailed Summary: 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.
Sponsor: University of Kentucky

Current Primary Outcome: The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Kentucky

Dates:
Date Received: September 17, 2009
Date Started: October 2008
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014