Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

University of California, Irvine

Overview

The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization. The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Port Wine Stain

Interventions

Topical AntiangiogenicDRUG

Topical Antiangiogenic

Pulsed Dye LaserDEVICE

Pulsed Dye Laser

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 16 years of age and older * Have PWS suitable for comparison testing as determined by the study doctor Exclusion Criteria: * Less than 16 years old * Are pregnant * Have skin cancer * Currently taking immunosuppressive or steroids or photosensitizing drugs * Current participation in any other investigational drug evaluation * Concurrent use of known photosensitizing drugs

Outcomes

Primary Outcomes

Improve PWS lesion blanching.

Time frame: 8 weeks

Secondary Outcomes

To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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