Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Primary Purpose
Port-Wine Stain
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ranibizumab
Pulsed Dye Laser
Sponsored by
About this trial
This is an interventional treatment trial for Port-Wine Stain focused on measuring port wine stain birthmarks
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ranibizumab
Pulsed Dye Laser
Arm Description
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
Outcomes
Primary Outcome Measures
Port Wine Stain response to laser treatment
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Secondary Outcome Measures
Full Information
NCT ID
NCT00667472
First Posted
April 24, 2008
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00667472
Brief Title
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Official Title
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
Keywords
port wine stain birthmarks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Arm Title
Pulsed Dye Laser
Arm Type
Experimental
Arm Description
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser
Intervention Description
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Primary Outcome Measure Information:
Title
Port Wine Stain response to laser treatment
Description
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John s Nelson, M.D,PhD
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
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