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

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00667472
First received: April 24, 2008
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

The purpose of this study is 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 ranibizumab will improve PWS therapeutic outcome.


Condition Intervention Phase
Port-Wine Stain
Drug: ranibizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • determine whether the combined use of PDL and topical ranibizumab will improve PWS therapeutic outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: combined laser and ranibizumab treatment
port wine stain birthmarks
Drug: ranibizumab
combined PDL laser and ranibizumab treatment

Detailed Description:

Combined use of PDL to induce PWS blood vessel injury, and ranibizumab to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Ranibizumab is a recombinant humanized monoclonal antibody fragment that works by attaching to and inhibiting the action of VEGF thereby preventing the growth and maintenance of blood vessels, which could be very useful in preventing PWS angiogenesis and recanalization.

After PDL treatment of the entire PWS, topical ranibizumab will be applied to two of the test sites for two weeks following PDL therapy. The degree of PWS blanching which will be quantified objectively using visible reflectance spectroscopy (VRS) measurements. PWS test site blanching responses following the combined use of PDL and topical ranibizumab will be compared with PDL only and with the baseline controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PWS 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667472

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

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00667472     History of Changes
Other Study ID Numbers: NIH-NIBIB, LAMMP-NIH
Study First Received: April 24, 2008
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
port wine stain birthmarks

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014