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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

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

NONE

Study Groups

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Topical Antiangiogenic

Topical Antiangiogenic Agents

Group Type EXPERIMENTAL

Topical Antiangiogenic

Intervention Type DRUG

Topical Antiangiogenic

Pulsed Dye Laser

Group Type EXPERIMENTAL

Pulsed Dye Laser

Intervention Type DEVICE

Pulsed Dye Laser

Interventions

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Topical Antiangiogenic

Intervention Type DRUG

Pulsed Dye Laser

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No