Combined Use of Pulsed Dye Laser and Topical Antiangiogen... | NCT00969397

Studies
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

NCT00969397

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 1, 2022Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Port Wine Stain

Interventions

Topical Antiangiogenic
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Withdrawn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

We have decided not to pursue the study

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

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, M.D., Ph.D.,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 researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Detailed Description

Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.

The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

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 1Phase 2

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
Topical Antiangiogenic	Experimental	Topical Antiangiogenic Agents	Drug: Topical Antiangiogenic
Pulsed Dye Laser	Experimental	Pulsed Dye Laser	Device: Pulsed Dye Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical Antiangiogenic	Drug	Topical Antiangiogenic	Topical Antiangiogenic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improve PWS lesion blanching.		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

16 years of age and older
Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

Less than 16 years old
Are pregnant
Have skin cancer
Currently taking immunosuppressive or steroids or photosensitizing drugs
Current participation in any other investigational drug evaluation
Concurrent use of known photosensitizing drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
D020533	Angiogenesis Inhibitors
D054025	Lasers, Dye

Ancestor Terms

ID	Term
D043924	Angiogenesis Modulating Agents
D006133	Growth Substances
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided