NCT00540917

Brief Summary

Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

7.7 years

First QC Date

October 4, 2007

Last Update Submit

October 28, 2022

Conditions

Port-Wine Stain

Outcome Measures

Primary Outcomes (1)

  • skin temperature during laser treatment

    90 days

Study Arms (1)

cooling spray

EXPERIMENTAL

cooling spray during laser treatment

Procedure: cooling spray during laser treatment

Interventions

cooling spray during laser treatmentPROCEDURE

skin temperature measurement

Also known as: laser treatment
cooling spray

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older with diagnosis of port wine stain birthmark
  • years of age and older with no port wine stain
  • non-pregnant women
  • apparent good health

You may not qualify if:

  • age less than 7 years old
  • pregnant women
  • history of photodermatoses or skin cancer
  • current use of photosensitizing drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical Clinic University of California Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • John S. Nelson, M.D., Ph.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
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

October 4, 2007

First Posted

October 8, 2007

Study Start

July 1, 2002

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)