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WithdrawnNCT00580944Updated Oct 20, 2022

Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

A Phase 1 interventional study of laser treatment of port wine stain birthmarks in Port Wine Stain, sponsored by University of California, Irvine. Withdrawn. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by University of California, Irvine · Phase 1, Interventional, and Treatment

Why this study was withdrawn
No participant enrolled
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks.

Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.

Read the detailed description

The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

02

Conditions studied

  • Port Wine Stain

Keywords

  • Port wine stain
  • progressive malformation of human skin
03

In context

Hemangioma, Capillary

83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.

Browse Hemangioma, Capillary studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Port Wine Stain suitable for comparison testing
  • Age > 12 years and older
  • minor will be accompanied by parents or guardians during laser treatment
  • Apparent good health as documented by medical history

Exclusion criteria

Exclusion Criteria:

  • History of photodermatoses or skin cancer
  • Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
  • Current participation in any other investigational drug or device evaluation
  • Concurrent use of known photosensitizing drugs
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Port Wien Stain Birthmark

    Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

    Procedure: laser treatment of port wine stain birthmarks

Interventions

  • Procedurelaser treatment of port wine stain birthmarks

    Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

06

What researchers measure

Primary outcomes

  1. Port Wine Stain Birthmarks blanching

    Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00580944
Lead sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
Responsible party
Beckman Laser Institute and Medical Center (J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine) — Principal investigator
First posted
Dec 27, 2007
Start date
Apr 2007
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Oct 20, 2022

Study contacts

JOHN S NELSON, M.D,Ph.D
principal investigator · Beckman Laser Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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