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

Phase 1

Withdrawn

• Conditions: Port Wine Stain
• Interventions: Drug: Topical Antiangiogenic; Device: Pulsed Dye Laser

• Registration Number: NCT00969397
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Study Start: 2009-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical Antiangiogenic	Topical Antiangiogenic	Topical Antiangiogenic Agents
Pulsed Dye Laser	Pulsed Dye Laser	Pulsed Dye Laser

Primary Outcome Measures

Name	Time	Method
Improve PWS lesion blanching.	8 weeks

Secondary Outcome Measures

Name	Time	Method
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.	8 weeks