ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Cutaneous Effects of Cryogen Spray Cooling

This study is enrolling participants by invitation only.
Information provided by University of California, Irvine

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Cutaneous Effects of Cryogen Spray Cooling
Official Title  Cutaneous Effects of Cryogen Spray Cooling
Brief Summary

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 (FDA) approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation.

Detailed Description

A millisecond cryogen 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 FDA.

The researcher' want to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns (single vs. multiple spurts) of CSC in Fitzpatrick skin types I-VI, 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. The number of subjects developing each type of skin response (erythema, blistering, hyperpigmentation, hypopigmentation, scarring, or other) will be reported for each cryogen spurt duration or spurt regimen and each skin type.

Study Phase Phase I
Study Type  Interventional
Study Design  Prevention, Non-Randomized, Open Label, Single Group Assignment
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Healthy
Intervention  Procedure: cryogen spray cooling
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  60
Start Date  January 2004
Completion Date July 2012
Eligibility Criteria 

Inclusion Criteria:

  • Adult 18 years and older

Exclusion Criteria:

  • Age <18
  • History of cold sensitivity
  • Inflammatory rash on the test site
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00581568
Organization ID #GM-08620:PHS-NIH
Secondary IDs †† P41-RR01192
Study Sponsor  University of California, Irvine
Collaborators †† Beckman Laser Institute Medical Clinic
Candela Laser Corporation
Investigators 
Study Chair:     John S Nelson, M.D.,Ph.D     Beckman laser Institute    
Information Provided By University of California, Irvine
Verification Date July 2008
First Received Date  December 19, 2007
Last Updated Date July 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers