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Cutaneous Effects of Cryogen Spray Cooling
This study is enrolling participants by invitation only.
Study NCT00581568   Information provided by University of California, Irvine
First Received: December 19, 2007   Last Updated: March 12, 2009   History of Changes

December 19, 2007
March 12, 2009
January 2004
July 2012   (final data collection date for primary outcome measure)
low incidence of clinical skin effects in any skin type. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
After laser treatment in combination with CSC,low incidence of clinical skin side effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00581568 on ClinicalTrials.gov Archive Site
 
 
 
Cutaneous Effects of Cryogen Spray Cooling
Cutaneous Effects of Cryogen Spray Cooling

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.

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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Healthy
Procedure: cryogen spray cooling
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
60
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult 18 years and older

Exclusion Criteria:

  • Age <18
  • History of cold sensitivity
  • Inflammatory rash on the test site
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581568
Wangcun Jia, Ph.D, Beckman Laser Institute
CAN-44711, LAMMP RR-01192-29
University of California, Irvine
  • Beckman Laser Institute University of California Irvine
  • Candela Corporation
Study Chair: John S Nelson, M.D.,Ph.D Beckman laser Institute
University of California, Irvine
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP