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Cutaneous Effects of Cryogen Spray Cooling (CSC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581568
First Posted: December 27, 2007
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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.

Condition Intervention Phase
Pain Other: Cutaneous Effects of Cryogen Spray Cooling Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cutaneous Effects of Cryogen Spray Cooling

Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Skin cooling during laser treatment [ Time Frame: 1 minute ]
    Cryogen Spray Cooling spray cooling skin during laser treatment


Enrollment: 53
Study Start Date: January 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Effects of Cryogen Spray Cooling
Cutaneous Effects of Cryogen Spray Cooling
Other: Cutaneous Effects of Cryogen Spray Cooling
Cutaneous Effects of Cryogen Spray Cooling
Other Name: CSC

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult 18 years and older

Exclusion Criteria:

  • Age <18
  • History of cold sensitivity
  • Inflammatory rash on the test site
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581568


Locations
United States, California
Beckman Laser Institute Medical and Surgical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Study Chair: John S Nelson, M.D.,Ph.D Beckman Laser Institute
Principal Investigator: Wangcun Jia, PhD Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Wangcun Jia, PhD., Research Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581568     History of Changes
Other Study ID Numbers: NIH-LAMMP-2003-3200
First Submitted: December 19, 2007
First Posted: December 27, 2007
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Skin cooling during laser treatment