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OpenTrials
Completed

NCT Number: NCT00540917

Measurement Skin Temperature During Pulsed Laser Exposure

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.

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Key information

Conditions

Port-Wine Stain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

7 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beckman Laser Institute Medical Clinic University of California Irvine

Irvine, California, 92612, United States

About this study

The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.

This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

cooling spray during laser treatment

Procedure

skin temperature measurement

Other names: laser treatment

Primary outcomes

  1. skin temperature during laser treatment

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine
  • Candela Corporation

Registry information

Official study title

Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2007
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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