Official Title: “Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks”

Port wine stains (PWS) are red birthmarks that without treatment persist for a lifetime.

They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating PWS is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the PDL treatment is likely an important factor in why these lesions persist despite therapy.

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2012

Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research' expect that it will have similar effects on port wine stains, but this has not yet been reported. This study is to determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions.

In this single center study, PWS subjects will receive treatment to their PWS with a laser in combination with epidermal cooling. The lasers to be utilized are FDA approved for treatment of PWS birthmarks and are currently used at the Beckman Laser Institute.

Starting the first post-treatment day, subjects will apply one sachet per 25 cm2 of treatment area of either imiquimod 5% cream or vehicle (placebo) cream to a limited area (25 cm2) of their PWS three days each week (eg, M-W-F or T-Th-S) for 8 weeks. At each dosing period, study drug should remain in place for 8±2 hrs (preferably during normal sleeping hours) and remain unoccluded.

Randomization to treatment or control group will occur after laser treatment of their PWS.

Subjects in either treatment arm will therefore receive equivalent laser therapy.

Intervention(s) in this Clinical Trial

• Drug: topical imiquimod 5% cream
  • one sachet per 25 cm2 of treatment area

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions.
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of PWS birthmark
• Male and female subjects of any age who are in good health.
• Fitzpatrick skin type I-VI

Exclusion Criteria:

• Pregnant or lactating
• History of cutaneous photosensitivity
• History of hypersensitivity to imiquimod 5% cream or any of its components
• History of photodermatoses

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of California, Irvine

Overall Clinical Trial Officials and Contacts

Kristen M Kelly, M.D Principal Investigator Beckman Laser Institute Medical Clinic  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00585247

Study ID Number: 3M-39936;3M

ClinicalTrials.gov Identifier: NCT00585247

Health Authority: United States: Institutional Review Board