Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 3:12 PM
Study NCT ID:
NCT03284034
Status:
TERMINATED
Last Update Posted:
2025-05-06
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}], 'ancestors': [{'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Unable to enroll participants for analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fat measurements from baseline to Day 90.', 'timeFrame': 'Baseline and Day 90', 'description': 'Subcutaneous fat measurement will be performed using an ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Upper Back Fat']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. The treatment sites are the right and left upper back fat areas. The right and left sides of the upper back fat will be randomly assigned (1:1) to receive cryolipolysis, while the contralateral side will receive ATX-101.\n\nThis study was a pilot study designed to determine feasibility of this procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females ≥ 18 years old\n2. Subjects are in good health as judged by the investigator.\n3. Subjects with mild to moderate upper back fat.\n4. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.\n\nExclusion Criteria:\n\n1. History of hypertrophic scars or keloids\n2. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder\n3. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.\n4. Pregnant or breast feeding\n5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.\n6. Subjects who are unable to understand the protocol or give informed consent.'}, 'identificationModule': {'nctId': 'NCT03284034', 'briefTitle': 'Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.', 'orgStudyIdInfo': {'id': 'STU00205070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyrolipolysis', 'interventionNames': ['Device: CoolCurve']}, {'type': 'EXPERIMENTAL', 'label': 'Deoxycholic Acid', 'interventionNames': ['Drug: ATX-101']}], 'interventions': [{'name': 'CoolCurve', 'type': 'DEVICE', 'otherNames': ['CoolSculpt'], 'description': 'The right and left sides of the upper back fat will be randomly assigned to receive Cryolypolysis (CoolCurve + Advantage applicator) 35 minutes session, 3 sessions 30 days apart.', 'armGroupLabels': ['Cyrolipolysis']}, {'name': 'ATX-101', 'type': 'DRUG', 'otherNames': ['Kybella'], 'description': 'The right and left sides of the upper back fat will be randomly assigned to receive The right and left sides of the upper back fat will be randomly assigned to receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.', 'armGroupLabels': ['Deoxycholic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Murad Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery', 'investigatorFullName': 'Murad Alam', 'investigatorAffiliation': 'Northwestern University'}}}}