Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks (Aldara)

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585247
First received: December 18, 2007
Last updated: December 26, 2012
Last verified: December 2012

December 18, 2007
December 26, 2012
November 2006
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00585247 on ClinicalTrials.gov Archive Site
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Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Port Wine Stain
Other: combined laser and imiquimod treatment
combined laser and imiquimod treatment
Experimental: combined laser and imiquimod treatment
port wine stain birthmarks
Intervention: Other: combined laser and imiquimod treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585247
3M-39936, LAMMP
Yes
Montana Compton, University of California, Irvine
Montana Compton
Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen M Kelly, M.D Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP