Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-28 @ 7:26 AM
Study NCT ID:
NCT03424161
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2018-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdoucette@cutera.com', 'phone': '415-656-9612', 'title': 'Margot Doucette', 'organization': 'Cutera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks post final treatment, up to 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Secret RF', 'description': 'Treatment with Secret RF for skin quality', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Aesthetic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Secret RF', 'description': 'Treatment with Secret RF for skin quality'}], 'classes': [{'title': 'GAIS at the 4 week follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'GAIS at the 12 week follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 4 weeks follow-up and 12 weeks follow-up', 'description': 'Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Secret RF', 'description': 'Treatment with Secret RF for skin quality'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Secret RF', 'description': 'Treatment with Secret RF for skin quality'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-03-29', 'size': 529476, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-12T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2018-01-25', 'resultsFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-12', 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Aesthetic Improvement', 'timeFrame': 'at 4 weeks follow-up and 12 weeks follow-up', 'description': 'Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Skin Quality']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.', 'detailedDescription': 'This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject must be able to read, understand and sign the Informed Consent Form.\n2. Female or Male, age 18 and older\n3. Willing to undergo treatments with Secret RF.\n4. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.\n5. Subject must adhere to the follow-up schedule and study instructions.\n6. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment area during the study and has no intention of having such procedures performed during the course of the study.\n7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.\n8. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.\n\nExclusion Criteria:\n\n1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.\n2. History of clotting disorders and/or current use of blood thinning medications.\n3. History of autoimmune disorders or diabetes.\n4. Cardiac pacemaker or active implantable metal device in the treatment area.\n5. Allergies to metals i.e. gold.\n6. Has a history of squamous cell carcinoma or melanoma in the treatment area.\n7. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.\n8. History of any disease or condition that could impair wound healing.\n9. History of keloid formation or abnormal/delayed wound healing.\n10. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.\n11. Use of topical agents one week prior to treatment that may cause facial sensitivity.\n12. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).\n13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements."}, 'identificationModule': {'nctId': 'NCT03424161', 'briefTitle': 'Multi-Center, Clinical Evaluation of the Cutera Secret RF Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cutera Inc.'}, 'officialTitle': 'Multi-Center, Clinical Evaluation of the Cutera Secret RF Device', 'orgStudyIdInfo': {'id': 'C-18-SRF01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Secret RF', 'description': 'Treatment with Secret RF for skin quality', 'interventionNames': ['Device: Secret RF']}], 'interventions': [{'name': 'Secret RF', 'type': 'DEVICE', 'description': 'Subjects will receive treatment with the Secret RF device', 'armGroupLabels': ['Secret RF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Cutera Research Center', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'Stephen Ronan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cutera Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cutera Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}