Measurement Skin Temperature During Pulsed Laser Exposure

Port-Wine Stain Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540917
• Other study ID #: 19992250
• Status: Completed
• Phase: Phase 2
• Start date: July 2002
• Est. completion date: March 2010

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Procedure:
• cooling spray during laser treatment
skin temperature measurement

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical Clinic University of California Irvine	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Candela Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin temperature during laser treatment		90 days