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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | March 12, 2009 | ||||
| Start Date ICMJE | January 2004 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
low incidence of clinical skin effects in any skin type. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00581568 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cutaneous Effects of Cryogen Spray Cooling | ||||
| Official Title ICMJE | Cutaneous Effects of Cryogen Spray Cooling | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Procedure: cryogen spray cooling | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00581568 | ||||
| Responsible Party | Wangcun Jia, Ph.D, Beckman Laser Institute | ||||
| Study ID Numbers ICMJE | CAN-44711, LAMMP RR-01192-29 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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