NCT00667472

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5.7 years

First QC Date

April 24, 2008

Last Update Submit

October 28, 2022

Conditions

Port-Wine Stain

Keywords

port wine stain birthmarks

Outcome Measures

Primary Outcomes (1)

  • Port Wine Stain response to laser treatment

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

    8 weeks

Study Arms (2)

Ranibizumab

EXPERIMENTAL

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

Drug: Ranibizumab

Pulsed Dye Laser

EXPERIMENTAL

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

Device: Pulsed Dye Laser

Interventions

RanibizumabDRUG

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

Ranibizumab
Pulsed Dye LaserDEVICE

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

Pulsed Dye Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Port-Wine Stain

Interventions

RanibizumabLasers, Dye

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • John s Nelson, M.D,PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 1, 2022

Record last verified: 2022-10