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

October 19, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute Medical and Surgical Cilnic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in a* and E at 8 Weeks
Time Frame: 8 weeks baseline
Change in a* and ΔE is a way to quantify PWS treatment outcome: a* is the erythema of the vascular lesions and varies from +60 for green to -60 for red with a value of +9.28 for Normal Skin. Higher a* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.
8 weeks baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Kristen M Kelly, M.D, Beckman Laser Institute University of California Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 3, 2008

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20064815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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