Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-22 @ 9:03 AM
Study NCT ID:
NCT00979550
Status:
TERMINATED
Last Update Posted:
2018-03-22
First Post:
2009-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Aldara as an Adjunct to Laser Treatment
Sponsor:
Henry Vasconez
Organization:
Study Overview
Official Title:
The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to enroll enough participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: