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| 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. |
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| 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. |
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| 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:
Exclusion Criteria:
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| 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 |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | December 19, 2007 | ||||
| Last Updated Date | May 22, 2008 | ||||