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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status and phase

Withdrawn
Phase 1

Conditions

Port-Wine Stain

Treatments

Drug: Ranibizumab
Device: Pulsed Dye Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT00667472
20076098

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

0 participants in 2 patient groups

Ranibizumab
Experimental group
Description:
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Treatment:
Drug: Ranibizumab
Pulsed Dye Laser
Experimental group
Description:
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Treatment:
Device: Pulsed Dye Laser

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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