Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT00581568
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cutaneous Effects of Cryogen Spray Cooling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin cooling during laser treatment', 'timeFrame': '1 minute', 'description': 'Cryogen Spray Cooling spray cooling skin during laser treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin cooling during laser treatment'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Cryogen Spray Cooling 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 Food and Drug Administration.', 'detailedDescription': 'The researcher can use laser treatment in combination with Cryogen Spray Cooling. The specific aim of this study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns 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.\n\nResearchers can use Cryogen Spray Cooling to protect the skin epidermis during laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences. Cryogen Spray Cooling 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years and older\n\nExclusion Criteria:\n\n* Age \\<18\n* History of cold sensitivity\n* Inflammatory rash on the test site'}, 'identificationModule': {'nctId': 'NCT00581568', 'acronym': 'CSC', 'briefTitle': 'Cutaneous Effects of Cryogen Spray Cooling', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Cutaneous Effects of Cryogen Spray Cooling', 'orgStudyIdInfo': {'id': '20033200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effects of Cryogen Spray Cooling', 'description': 'Cutaneous Effects of Cryogen Spray Cooling', 'interventionNames': ['Other: Cutaneous Effects of Cryogen Spray Cooling']}], 'interventions': [{'name': 'Cutaneous Effects of Cryogen Spray Cooling', 'type': 'OTHER', 'otherNames': ['CSC'], 'description': 'Cutaneous Effects of Cryogen Spray Cooling', 'armGroupLabels': ['Effects of Cryogen Spray Cooling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Laser Institute Medical and Surgical clinic', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'John S Nelson, M.D.,Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Beckman Laser Institute'}, {'name': 'Wangcun Jia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckman Laser Institute University of California Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wangcun Jia, PhD., Research Scientist', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}