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

Port Wine Stain Clinical Trial

— Aldara  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585247
• Other study ID #: 20064815
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: August 2012

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Intervention

Drug:
• Imiquimod
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

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical and Surgical Cilnic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in a* and E at 8 Weeks	Change in a* and ?E 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. ?E detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ?E is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.	8 weeks baseline

External Links

•   Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod