Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-30 @ 5:43 AM
Study NCT ID:
NCT03776461
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Sponsor:
Organization:
Raw JSON
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Assessment at Week 20.\n\nVenus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks Post Last Treatment (Around Week 20)', 'description': "Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': '3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 14.\n\nVenus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks Post Last Treatment (Around Week 14)', 'description': "Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Scale - Visual Analog Scale for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': '3 treatments with Viva at 0, 4, and 8 weeks. Assessment immediately post-treatment.\n\nVenus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Treatment at the Baseline, 4 Week and 8 Week treatment visits', 'description': "Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': '3 treatments with Viva at 0, 4, and 8 weeks. Assessment immediately post-treatment\n\nVenus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Treatment at the Baseline, 4 Week and 8 Week treatment visits', 'description': "Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '80-pin Applicator', 'description': '3 treatments with either the Venus Viva 80-pin or 160-tip applicator at 0, 4, and 8 weeks.\n\nVenus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', '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'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'VI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Fitzpatrick scale is a numerical classification schema for human skin color. Higher numbers mean darker skin.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-05', 'size': 726368, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-21T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Evaluator blinded assessment of photographs'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single centre, evaluator-blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2018-12-12', 'resultsFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-14', 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Satisfaction', 'timeFrame': '12 Weeks Post Last Treatment (Around Week 20)', 'description': "Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment."}, {'measure': 'Subject Satisfaction', 'timeFrame': '6 Weeks Post Last Treatment (Around Week 14)', 'description': "Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment."}], 'secondaryOutcomes': [{'measure': 'Subject Scale - Visual Analog Scale for Pain', 'timeFrame': 'Post Treatment at the Baseline, 4 Week and 8 Week treatment visits', 'description': "Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments."}, {'measure': 'Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.', 'timeFrame': 'Post Treatment at the Baseline, 4 Week and 8 Week treatment visits', 'description': "Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['fractional radiofrequency', 'fractional RF', 'facial wrinkles', 'wrinkles'], 'conditions': ['Rhytides', 'Wrinkle']}, 'descriptionModule': {'briefSummary': 'Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.', 'detailedDescription': 'The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.\n2. Able to read, understand and voluntarily provide written Informed Consent.\n3. Able and willing to comply with the treatment/follow-up schedule and requirements.\n4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.\n\nExclusion Criteria:\n\n1. Implantable defibrillators, cardiac pacemakers, and other metal implants\n2. Subjects with any implantable metal device in the treatment area\n3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).\n4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.\n5. Current or history of any kind of cancer, or pre-malignant moles.\n6. Severe concurrent conditions, such as cardiac disorders.\n7. Pregnancy or intending to become pregnant during the study and nursing.\n8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.\n9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment , or according to Investigator's discretion .\n10. Poorly controlled endocrine disorders, such as diabetes.\n11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.\n12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.\n13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).\n14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.\n15. Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.\n16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.\n17. Any surgical procedure in the treatment area within the last six months or before complete healing.\n18. Treating over tattoo or permanent makeup.\n19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.\n20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient."}, 'identificationModule': {'nctId': 'NCT03776461', 'briefTitle': 'Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venus Concept'}, 'officialTitle': 'Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles', 'orgStudyIdInfo': {'id': 'VI0918'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '80-pin applicator', 'description': '3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks.', 'interventionNames': ['Device: Venus Viva']}, {'type': 'ACTIVE_COMPARATOR', 'label': '160 pin applicator', 'description': '3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks.', 'interventionNames': ['Device: Venus Viva']}], 'interventions': [{'name': 'Venus Viva', 'type': 'DEVICE', 'description': 'The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.', 'armGroupLabels': ['160 pin applicator', '80-pin applicator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic Carmel Valley', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Matthew Gronski', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Venus Concept'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venus Concept', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}