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):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585247
First received: December 18, 2007
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

Port wine stains 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 Port wine stains 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 Laser treatment is likely an important factor in why these lesions persist despite therapy.


Condition Intervention
Port Wine Stain
Drug: Imiquimod
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Port Wine Stain Blanching [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    The percentage of Port Wine Stain Blanching (in increments of 10%) compare mean baseline reflectance measurements to post-treatment reflectance measurements.


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: Imiquimod
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Drug: Imiquimod
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Other Name: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser
Placebo Comparator: Placebo
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Other: Placebo
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Other Name: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

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 can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Port Wine Stain 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
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen M Kelly, M.D Beckman Laser Institute University of California Irvine
  More Information

Additional Information:
Publications:
Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585247     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-4815
Study First Received: December 18, 2007
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

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 July 30, 2015