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

University of California Irvine (UCI)

Status: Completed

Conditions: Port Wine Stain

Treatments: Other: Placebo; Drug: Imiquimod

Study type: Interventional

Funder types: Other

Identifiers

NCT00585247

20064815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Imiquimod

Experimental group

Description:

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

Treatment:

Drug: Imiquimod

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo