Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT02744794
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Dermal Cryotherapy System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin pigmentation changes', 'timeFrame': '90 days', 'description': 'Changes in pigmentation graded using a 7-point standardized scale'}], 'secondaryOutcomes': [{'measure': 'Evaluation of device- or procedure-related adverse events', 'timeFrame': '0 to 12 months', 'description': 'Side effects, discomfort assessments both during treatment and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Skin Lightening']}, 'descriptionModule': {'briefSummary': 'A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.', 'detailedDescription': 'This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects \\> 18 years of age.\n2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.\n3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.\n4. Subject has read and signed a written informed consent form.\n\nExclusion Criteria:\n\n1. Fitzpatrick skin type VI.\n2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)\n3. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period\n4. Dermatological conditions or scars in the location of the treatment sites\n5. History of melanoma, personal or first degree relative\n6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.\n7. History of abnormal wound healing or abnormal scarring\n8. Inability or unwillingness to comply with study requirments.\n9. Current enrollment in a clinical study of any other unapproved investigational drug or device.\n10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject."}, 'identificationModule': {'nctId': 'NCT02744794', 'briefTitle': 'Evaluation of a New Dermal Cryotherapy System', 'organization': {'class': 'INDUSTRY', 'fullName': 'R2 Dermatology'}, 'officialTitle': 'Evaluation of a New Dermal Cryotherapy System', 'orgStudyIdInfo': {'id': 'R2-15-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with cryotherapy', 'description': 'Treatment with dermal cooling system.', 'interventionNames': ['Device: Dermal Cooling System']}], 'interventions': [{'name': 'Dermal Cooling System', 'type': 'DEVICE', 'description': 'Treatment with cryotherapy.', 'armGroupLabels': ['Treatment with cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Center of Dermatology and Laser Surgery', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowes Dermatology', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Kristine Tatsutani, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'R2 Dermatology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R2 Dermatology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}