Combined Pulsed Dye Laser and Topical Ranibizumab for Tre... | NCT00667472

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

NCT00667472

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 1, 2022Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Port-Wine Stain

Interventions

Ranibizumab
Pulsed Dye Laser

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 24, 2008

First Submission Date that Met QC Criteria

Apr 25, 2008

First Posted Date

Apr 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks	Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Port Wine Stain response to laser treatment	Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John s Nelson, M.D,PhD	Beckman Laser Institute University of California Irvine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019339	Port-Wine Stain

Ancestor Terms

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab
D054025	Lasers, Dye

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided