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

Primary Purpose

Port Wine Stain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imiquimod
Placebo
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port Wine Stain focused on measuring birthmarks

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beckman Laser Institute Medical and Surgical Cilnic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Imiquimod

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Change From Baseline in a* and E at 8 Weeks
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
October 19, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00585247
Brief Title
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Acronym
Aldara
Official Title
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
birthmarks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod
Arm Type
Experimental
Arm Description
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser
Intervention Description
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser
Intervention Description
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Primary Outcome Measure Information:
Title
Change From Baseline in a* and E at 8 Weeks
Description
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.
Time Frame
8 weeks baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen M Kelly, M.D
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical and Surgical Cilnic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22244840
Citation
Tremaine AM, Armstrong J, Huang YC, Elkeeb L, Ortiz A, Harris R, Choi B, Kelly KM. Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod. J Am Acad Dermatol. 2012 Apr;66(4):634-41. doi: 10.1016/j.jaad.2011.11.958. Epub 2012 Jan 14.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22244840
Description
Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod

Learn more about this trial

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

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