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

Not Applicable

Completed

• Conditions: Port Wine Stain
• Interventions: Other: Placebo; Drug: Imiquimod

• Registration Number: NCT00585247
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2015-08-25
• Results First Submitted QC: 2018-03-06
• Results First Posted: 2018-04-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beckman Laser Institute Medical and Surgical Cilnic; 🇺🇸 Irvine, California, United States