Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Information source: University of California, Irvine
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Port Wine Stain
Intervention: topical imiquimod 5% cream (Drug)
Phase: Phase 1
Status: Enrolling by invitation
Sponsored by: University of California, Irvine Official(s) and/or principal investigator(s):
Kristen M Kelly, M.D, Principal Investigator, Affiliation: Beckman Laser Institute Medical Clinic
Summary
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.
Clinical Details
Official title: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Study design: Other, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study
Primary outcome: determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions.
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Beckman Laser Institute Medical and Surgical Cilnic, Irvine, California 92612, United States
Additional Information
Starting date: November 2006
Ending date: July 2012
Last updated: March 26, 2008
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