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

NCT00585247 | Completed Results DMC

• 1 other identifier: 20064815
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Port Wine Stain

Keywords

birthmarks

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in a* and E at 8 Weeks

  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.

  8 weeks baseline

Study Arms (2)

Imiquimod

EXPERIMENTAL

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

Drug: Imiquimod

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Imiquimod DRUG

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

Also known as: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

Imiquimod

Placebo OTHER

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

Also known as: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Port Wine Stain birthmark
• Male and female subjects of any age who are in good health.
• Fitzpatrick skin type I-VI

You may not qualify if:

• Pregnant or lactating
• History of cutaneous photosensitivity
• History of hypersensitivity to imiquimod 5% cream or any of its components
• History of photodermatoses

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute Medical and Surgical Cilnic

Irvine, California, 92612, United States

Location

Related 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.jaad.2011.11.958. Epub 2012 Jan 14.

  PMID: 22244840 RESULT

Related Links

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

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Effects were evaluated after a single treatment and duration of effect is unknown

Results Point of Contact

• Title: Dr. Kristen Kelly
• Organization: University of Ccalifornia, Irvine. Beckman Laser Institute

kmkelly@uci.edu

949.824.7997

Study Officials

• Kristen M Kelly, M.D

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: January 3, 2008
• Study Start: November 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 21, 2022
• Results First Posted: April 4, 2018

Record last verified: 2022-10

Locations

US (1)