Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks - Tabular View

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

March 12, 2009

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00585247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Port Wine Stain

Intervention ^ICMJE

Drug: topical imiquimod 5% cream

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00585247

Responsible Party

Kristen Kelly, M.D, Beckman Laseer Institute

Study ID Numbers ^ICMJE

3M-39936;3M, graceway pharma., P41-RR01192;NIH-LAMMP

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Beckman Laser Institute University of California Irvine
Graceway Pharmaceuticals, LLC
Sturge-Weber Foundation

Investigators ^ICMJE

Principal Investigator:

Kristen M Kelly, M.D

Beckman Laser Institute University of California Irvine

Information Provided By

University of California, Irvine

Verification Date

March 2009

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