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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
  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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585247

Locations
United States, California
Beckman Laser Institute Medical and Surgical Cilnic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
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
Congenital Abnormalities
Skin Abnormalities
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014