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Measurement Skin Temperature During Pulsed Laser Exposure

Primary Purpose

Port-Wine Stain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cooling spray during laser treatment
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-Wine Stain

Eligibility Criteria

7 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beckman Laser Institute Medical Clinic University of California Irvine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cooling spray

Arm Description

cooling spray during laser treatment

Outcomes

Primary Outcome Measures

skin temperature during laser treatment

Secondary Outcome Measures

Full Information

First Posted
October 4, 2007
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Candela Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00540917
Brief Title
Measurement Skin Temperature During Pulsed Laser Exposure
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Candela Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cooling spray
Arm Type
Experimental
Arm Description
cooling spray during laser treatment
Intervention Type
Procedure
Intervention Name(s)
cooling spray during laser treatment
Other Intervention Name(s)
laser treatment
Intervention Description
skin temperature measurement
Primary Outcome Measure Information:
Title
skin temperature during laser treatment
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S. Nelson, M.D., Ph.D
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical Clinic University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

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Measurement Skin Temperature During Pulsed Laser Exposure

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