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

NCT ID: NCT00667472

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Port-Wine Stain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ranibizumab

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

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

Pulsed Dye Laser

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

Group Type EXPERIMENTAL

Pulsed Dye Laser

Intervention Type DEVICE

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

Interventions

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Ranibizumab

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

Intervention Type DRUG

Pulsed Dye Laser

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John s Nelson, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Other Identifiers

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20076098

Identifier Type: -

Identifier Source: org_study_id

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