Cutaneous Effects of Cryogen Spray Cooling - Full Text View

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute University of California Irvine Candela Corporation
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581568

Purpose

Researchers preliminary studies with epoxy skin phantoms have shown that liquid CO2 spray is effective to protect the epidermis during dermatologic laser therapy. This study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns of CSC in Fitzpatrick skin types I-VI.

However, the lower temperature induced by CO2 spray may tend to cause stronger cutaneous effects. It is researchers hypothesis that spurt durations of 80 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.

Condition	Intervention	Phase
Healthy	Procedure: cryogen spray cooling	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Cutaneous Effects of Cryogen Spray Cooling

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

Primary Outcome Measures:

low incidence of clinical skin effects in any skin type. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	January 2004
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: cryogen spray cooling Tetrafluoroethane Procedure: cryogen spray cooling tetrafluoroethane

Detailed Description:

Cryogen spray cooling (CSC) is a method to cool and thus, protect the epidermis which is used with dermatologic laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences.

CSC 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. A millisecond cryogen spurt is applied to the skin surface immediately before laser exposure.

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

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

Candela Corporation

Investigators

Study Chair:

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

Beckman laser Institute

More Information

No publications provided

Responsible Party:	Beckman Laser Institute ( Wangcun Jia, Ph.D )
Study ID Numbers:	CAN-44711, LAMMP RR-01192-29
Study First Received:	December 19, 2007
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00581568 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

protect the epidermis during skin laser treatment

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 02, 2009