NCT00969397

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.

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 Nov 2009

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

August 31, 2009

Last Update Submit

October 28, 2022

Conditions

Port Wine Stain

Keywords

BirthmarkPWS

Outcome Measures

Primary Outcomes (1)

  • Improve PWS lesion blanching.

    8 weeks

Secondary Outcomes (1)

  • To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.

    8 weeks

Study Arms (2)

Topical Antiangiogenic

EXPERIMENTAL

Topical Antiangiogenic Agents

Drug: Topical Antiangiogenic

Pulsed Dye Laser

EXPERIMENTAL

Pulsed Dye Laser

Device: Pulsed Dye Laser

Interventions

Topical AntiangiogenicDRUG

Topical Antiangiogenic

Topical Antiangiogenic
Pulsed Dye LaserDEVICE

Pulsed Dye Laser

Pulsed Dye Laser

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Angiogenesis InhibitorsLasers, Dye

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating AgentsGrowth SubstancesPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGrowth InhibitorsAntineoplastic AgentsTherapeutic UsesLasersOptical 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
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 1, 2022

Record last verified: 2022-10