Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-04 @ 9:51 PM
Study NCT ID:
NCT03282994
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermal Cooling System for Cryotherapy of Common Skin Conditions
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': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in appearance in the treatment area', 'timeFrame': '3-months', 'description': 'Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).'}], 'secondaryOutcomes': [{'measure': 'Incidence of procedure related adverse events', 'timeFrame': 'less than 12 months', 'description': '• Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Skin Lesion']}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.', 'detailedDescription': 'The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.'}, '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 has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.\n3. Subject is willing to have up to 40 test sites treated.\n4. Subject has read and signed a written informed consent form.\n\nExclusion Criteria:\n\n1. Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).\n2. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.\n3. History of melanoma.\n4. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).\n5. History of abnormal wound healing or abnormal scarring\n6. Inability or unwillingness to comply with the study requirements.\n7. Subject is pregnant or planning to become pregnant while enrolled in the study.\n8. Subject is lactating.\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 increased or unacceptable risk to the subject."}, 'identificationModule': {'nctId': 'NCT03282994', 'briefTitle': 'Dermal Cooling System for Cryotherapy of Common Skin Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'R2 Dermatology'}, 'officialTitle': 'Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions', 'orgStudyIdInfo': {'id': 'R2-17-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with cryotherapy', 'description': 'Dermal Cooling System', 'interventionNames': ['Device: Dermal Cooling System']}], 'interventions': [{'name': 'Dermal Cooling System', 'type': 'DEVICE', 'description': 'Cryotherapy', 'armGroupLabels': ['Treatment with cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clear Dermatology & Aesthetics Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55424', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Zel Skin and Laser Specialists', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser and Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Kristine Tatsutani, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'R2 Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R2 Dermatology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}