Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 6:02 PM
Study NCT ID:
NCT05097157
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D057896', 'term': 'Striae Distensae'}, {'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.trimper@cynosure.com', 'phone': '(978) 256-4200', 'title': 'Jamie Trimper', 'organization': 'Cynosure'}, 'certainAgreement': {'otherDetails': 'The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Subject data was collected throughout subject participation in the study, approximately 9 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 37, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pinpoint bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scabbing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Textural Irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breakout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Streaking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stabbing sensastion post pinpoint bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye twitch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash/skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Histamine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blanching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pinpoint dots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pustule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'classes': [{'categories': [{'title': 'Extremely Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Slightly Satisfied', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Slightly Dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Extremely Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 day follow up', 'description': 'Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 subjects were considered complete but did not have satisfaction information from their 30 day follow up.'}, {'type': 'PRIMARY', 'title': 'Global Aesthetic Improvement Scale Assessment (GAIS) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 day follow up', 'description': 'The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 subjects were considered complete but did not have satisfaction information from their 30 day follow up.'}, {'type': 'PRIMARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'treatment areas', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'classes': [{'title': 'Extremely Satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Slightly Satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Slightly Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Extremely Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 day follow up', 'description': 'Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.', 'unitOfMeasure': 'treatment areas', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'treatment areas', 'denomUnitsSelected': 'treatment areas', 'populationDescription': '40 subjects did not complete the 90 day follow up for the subject satisfaction However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a satisfaction score taken for both treatment areas.'}, {'type': 'PRIMARY', 'title': 'Global Aesthetic Improvement Scale Assessment (GAIS) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Treatment areas', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 day follow up', 'description': 'The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.', 'unitOfMeasure': 'treatment areas', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatment areas', 'denomUnitsSelected': 'Treatment areas', 'populationDescription': '41 subjects did not complete the 90 day follow up for the CGAIS. However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a CGAIS taken for both treatment areas.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.\n\nPotenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "One subject was 72 years old and was given permission to enroll in the study per the investigator's discretion.", 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Algerian/French', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FitzPatrick Skin Type', 'classes': [{'categories': [{'title': 'Fitzpatrick Skin Type I', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type II', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type III', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type IV', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type V', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Fitzpatrick Skin Type VI', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is.\n\nThe scale used is cited in the reference section', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-07', 'size': 634442, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-26T09:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-10-15', 'resultsFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-18', 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Satisfaction', 'timeFrame': '30 day follow up', 'description': 'Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.'}, {'measure': 'Global Aesthetic Improvement Scale Assessment (GAIS) Assessment', 'timeFrame': '30 day follow up', 'description': 'The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.'}, {'measure': 'Subject Satisfaction', 'timeFrame': '90 day follow up', 'description': 'Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.'}, {'measure': 'Global Aesthetic Improvement Scale Assessment (GAIS) Assessment', 'timeFrame': '90 day follow up', 'description': 'The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wrinkle', 'Fine Lines', 'Crepey Skin', 'Acne Scars', 'Acne', 'Enlarged Pores', 'Stretch Marks', 'Loose Skin']}, 'referencesModule': {'references': [{'pmid': '31896400', 'type': 'RESULT', 'citation': 'Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A healthy, non-smoking male or female between the age of 18-55 years old.\n* Fitzpatrick skin type I to VI.\n* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.\n* Understands and accepts the obligation and is logistically able to be present for all visits.\n* Is willing to comply with all requirements of the study and sign the informed consent document.\n\nExclusion Criteria:\n\n* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.\n* The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.\n* The subject has physical problems such as cardiovascular disorders.\n* The subject has a pacemaker.\n* The subject had previous use of gold thread skin rejuvenation.\n* The subject has skin infections.\n* The subject has any of the following conditions:\n\n * Diabetes\n * Epilepsy\n * Acute disease\n * Dermatitis\n* Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.\n* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation."}, 'identificationModule': {'nctId': 'NCT05097157', 'briefTitle': 'Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'officialTitle': 'Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions', 'orgStudyIdInfo': {'id': 'CYN19-RF-MN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Device', 'description': 'Subjects received up to 5 treatments with the device, spaced 4 weeks apart.', 'interventionNames': ['Device: Potenza']}], 'interventions': [{'name': 'Potenza', 'type': 'DEVICE', 'description': 'Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.', 'armGroupLabels': ['Treatment with Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology and Laser Surgery', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Dermatology Laser, Skin, & Vein Institute, LLC.', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '01886', 'city': 'Westford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cynosure', 'geoPoint': {'lat': 42.57926, 'lon': -71.43784}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'McDaniel Institute of Anti-Aging Research', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Jennifer Civiok', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cynosure, Inc.'}, {'name': 'Sean Doherty', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cynosure, Inc.'}, {'name': 'Robert Weiss', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maryland Dermatology Laser, Skin, & Vein Institute, LLC'}, {'name': 'Emil Tanghetti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Dermatology and Laser Surgery'}, {'name': 'David McDaniel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McDaniel Institute of Anti-Aging Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}