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

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ClinicalTrials.gov Identifier: NCT00585247
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

December 18, 2007
January 3, 2008
August 25, 2015
April 4, 2018
April 4, 2018
November 2006
August 2012   (Final data collection date for primary outcome measure)
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.
determine if applying imiquimod cream to PWS after laser therapy will improve lightening of these lesions. [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00585247 on ClinicalTrials.gov Archive Site
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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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Port Wine Stain
  • 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
  • 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
  • Experimental: Imiquimod
    Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
    Intervention: Drug: Imiquimod
  • Placebo Comparator: Placebo
    Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
20
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00585247
NIH-LAMMP-2006-4815
Yes
Not Provided
Not Provided
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen M Kelly, M.D Beckman Laser Institute University of California Irvine
University of California, Irvine
March 2018

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