NCT00979550

The Effects of Aldara as an Adjunct to Laser Treatment

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Henry Vasconez · Academic / Other
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Port Wine Stains

Interventions

Type	Name	Description
DRUG	Imiquimod	commercially available topical antiviral drug
DRUG	non-medicated petroleum cream	Over the counter topical cream used to aid the healing process in skin lesions

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2009-09-18
• Last updated: 2018-03-22
• Results posted: 2018-03-22

Locations

1 site across 1 country: United States