Cutaneous Effects of Cryogen Spray Cooling (CSC)

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581568
First received: December 19, 2007
Last updated: June 10, 2015
Last verified: June 2015
  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: Open Label
Primary Purpose: Treatment
Official Title: Cutaneous Effects of Cryogen Spray Cooling

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Skin cooling during laser treatment [ Time Frame: 1 minute ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 19, 2007
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Skin cooling during laser treatment

ClinicalTrials.gov processed this record on July 01, 2015