Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Phase 1

Withdrawn

• Conditions: Port-Wine Stain
• Interventions: Device: Pulsed Dye Laser; Drug: Ranibizumab

• Registration Number: NCT00667472
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser therapy and topical ranibizumab will improve port wine stain therapeutic outcome.

Detailed Description

Combined use of pulsed dye laser to induce port wine stain blood vessel injury, and ranibizumab to prevent port wine stain blood vessel angiogenesis and recanalization after laser therapy, will improve port wine stain lesion blanching.

After pulsed dye laser treatment of the entire port wine stain, topical ranibizumab will be applied to two of the test sites for two weeks following pulsed dye laser therapy. The degree of port wine stain blanching which will be quantified objectively using visible reflectance spectroscopy measurements. port wine stain test site blanching responses following the combined use of pulsed dye laser and topical ranibizumab will be compared with pulsed dye laser only and with the baseline controls.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Primary Completion: 2013-11
• Study Completion: 2013-11
• 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• Status: WITHDRAWN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

• Port Wine Stain suitable for comparison testing
• Age > 18 years of age

Exclusion Criteria

• History of photodermatoses or skin cancer
• use of known photosensitizing drugs
• use of immunosuppressive drugs or systemic steroids
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed Dye Laser	Pulsed Dye Laser	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Ranibizumab	Ranibizumab	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Primary Outcome Measures

Name	Time	Method
Port Wine Stain response to laser treatment	8 weeks	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks