Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks (Aldara)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Port Wine Stain |
Other: combined laser and imiquimod treatment |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks |
- determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | November 2006 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: combined laser and imiquimod treatment
port wine stain birthmarks
|
Other: combined laser and imiquimod treatment
combined laser and imiquimod treatment
|
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 everyday 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Beckman Laser Institute Medical and Surgical Cilnic | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Kristen M Kelly, M.D | Beckman Laser Institute University of California Irvine |
More Information
No publications provided
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00585247 History of Changes |
| Other Study ID Numbers: | 3M-39936, LAMMP |
| Study First Received: | December 18, 2007 |
| Last Updated: | December 26, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by University of California, Irvine:
|
birthmarks |
Additional relevant MeSH terms:
|
Port-Wine Stain Skin Abnormalities Congenital Abnormalities Skin Diseases Imiquimod Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on May 21, 2013