Cutaneous Effects of Cryogen Spray Cooling

NCT ID: NCT00581568

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

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-09-30

Brief Summary

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Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure. As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple studies to be a safe and effective cooling agent and is the only cryogenic compound currently approved for dermatologic use by the Food and Drug Administration.

Detailed Description

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The researcher can use laser treatment in combination with Cryogen Spray Cooling. The specific aim of this study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns that spurt durations of 100 ms or less will result in a very low incidence (less than 2%) of clinical skin effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type.

Researchers can use Cryogen Spray Cooling to protect the skin epidermis during laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences. Cryogen Spray Cooling with Tetrafluoroethane has been incorporated into many Food and Drug Administration approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation.

Conditions

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Pain

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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Effects of Cryogen Spray Cooling

Cutaneous Effects of Cryogen Spray Cooling

Group Type EXPERIMENTAL

Cutaneous Effects of Cryogen Spray Cooling

Intervention Type OTHER

Cutaneous Effects of Cryogen Spray Cooling

Interventions

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Cutaneous Effects of Cryogen Spray Cooling

Cutaneous Effects of Cryogen Spray Cooling

Intervention Type OTHER

Other Intervention Names

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CSC

Eligibility Criteria

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Inclusion Criteria

* Adult 18 years and older

Exclusion Criteria

* Age \<18
* History of cold sensitivity
* Inflammatory rash on the test site
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Wangcun Jia, PhD., Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

Beckman Laser Institute

Wangcun Jia, PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute

Locations

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Beckman Laser Institute Medical and Surgical clinic

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20033200

Identifier Type: -

Identifier Source: org_study_id

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