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

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ClinicalTrials.gov Identifier: NCT00667472
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : April 28, 2008
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, 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.

Condition or disease Intervention/treatment Phase
Port-Wine Stain Drug: Ranibizumab Device: Pulsed Dye Laser Phase 1

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Study Start Date : March 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667472


Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: John s Nelson, M.D,PhD Beckman Laser Institute University of California Irvine

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00667472     History of Changes
Other Study ID Numbers: NIH-NIBIB-LAMMP-2007-6098
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
port wine stain birthmarks

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents