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

NCT ID: NCT00585247

Last Updated: 2022-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Port Wine Stain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Imiquimod

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

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Imiquimod

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen M Kelly, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Institute Medical and Surgical Cilnic

Irvine, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22244840 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22244840

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

Other Identifiers

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20064815

Identifier Type: -

Identifier Source: org_study_id

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