Measurement Skin Temperature During Pulsed Laser Exposure

NCT ID: NCT00540917

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Port-Wine Stain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cooling spray

cooling spray during laser treatment

Group Type EXPERIMENTAL

cooling spray during laser treatment

Intervention Type PROCEDURE

skin temperature measurement

Interventions

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cooling spray during laser treatment

skin temperature measurement

Intervention Type PROCEDURE

Other Intervention Names

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laser treatment

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

Candela Corporation

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John S. Nelson, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Institute Medical Clinic University of California Irvine

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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19992250

Identifier Type: -

Identifier Source: org_study_id

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