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

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Drug: Ranibizumab
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Experimental: Pulsed Dye Laser
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Device: Pulsed Dye Laser
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Port Wine Stain response to laser treatment
Time Frame: 8 weeks
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: John S Nelson, M.D,PhD, Beckman Laser Institute University of California Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20076098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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