CClinicalTrials.gg
WithdrawnNCT00667472Updated Nov 1, 2022

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

A Phase 1 interventional study of Ranibizumab and Pulsed Dye Laser in Port-Wine Stain, sponsored by University of California, Irvine. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by University of California, Irvine · Phase 1, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Port-Wine Stain

Keywords

  • port wine stain birthmarks
03

In context

Hemangioma, Capillary

83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.

Browse Hemangioma, Capillary studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Port Wine Stain suitable for comparison testing
  • Age > 18 years of age

Exclusion criteria

Exclusion Criteria:

  • History of photodermatoses or skin cancer
  • use of known photosensitizing drugs
  • use of immunosuppressive drugs or systemic steroids
  • Pregnancy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Ranibizumab

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

    Drug: Ranibizumab

  • Experimental
    Pulsed Dye Laser

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

    Device: Pulsed Dye Laser

Interventions

  • DrugRanibizumab

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

  • DevicePulsed Dye Laser

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

06

What researchers measure

Primary outcomes

  1. Port Wine Stain response to laser treatment

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

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00667472
Lead sponsor
University of California, Irvine
Collaborators
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) — Principal investigator
First posted
Apr 28, 2008
Start date
Mar 2008
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 1, 2022

Study contacts

John s Nelson, M.D,PhD
principal investigator · Beckman Laser Institute University of California Irvine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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