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

This study is enrolling participants by invitation only.
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: December 27, 2012
Last verified: December 2012
History of Changes

April 24, 2008
December 27, 2012
March 2008
March 2013   (final data collection date for primary outcome measure)
determine whether the combined use of PDL and topical ranibizumab will improve PWS therapeutic outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00667472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Port-Wine Stain
Drug: ranibizumab
combined PDL laser and ranibizumab treatment
Experimental: combined laser and ranibizumab treatment
port wine stain birthmarks
Intervention: Drug: ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667472
NIH-NIBIB, LAMMP-NIH
Yes
Montana Compton, University of California, Irvine
Montana Compton
Genentech
Principal Investigator: John s Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP