Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT04881058
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2021-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}}}}, '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': 'Adverse events were collected from up to 9 months from the baseline', 'eventGroups': [{'id': 'EG000', 'title': 'PicoSure Device', 'description': 'The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.\n\nRF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'photographs', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PicoSure Device', 'description': 'The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.\n\nRF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 month follow up', 'description': 'Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.', 'unitOfMeasure': '% of photos correctly identified', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'photographs', 'denomUnitsSelected': 'photographs'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PicoSure Device', 'description': 'The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.\n\nRF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PicoSure Device', 'description': 'The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.\n\nRF Non-Invasive Treatment: Self-controlled single-arm group using the PicoSure device.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FitzPatrick Skin Type', 'classes': [{'title': 'Fitzpatrick Skin Type I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Type II', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Type III', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Type IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Type V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Type VI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects were graded on a Fitzpatrick Skin Type scale from I-VI, with I representing a low melanin content, and VI representing a higher melanin content. This grading criteria/scale comes from the reference listed in the protocol section.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-20', 'size': 778650, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-24T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2021-05-03', 'resultsFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-02', 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment', 'timeFrame': '3 month follow up', 'description': 'Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pigmentation', 'Wrinkle']}, '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': 'The intended use of the PicoSure device with focus lens array used in this study is to assess images to support additional marketing claims for the treatment of pigmentation and mild to moderate wrinkles.', 'detailedDescription': 'Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face with the PicoSure device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A healthy male or female 18 - 65 years of age.\n* Willing to undergo treatments for pigmentation and/or mild to moderate wrinkles on the face with the PicoSure device.\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 hypersensitive to light in the near infrared wavelength region.\n* The subject takes medication which is known to increase sensitivity to sunlight.\n* The subject has seizure disorders triggered by light.\n* The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.\n* The subject has an active localized or systemic infection, or an open wound in area being treated.\n* The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.\n* The subject has common acquired nevi that are predisposed to the development of malignant melanoma.\n* The subject has herpes simplex in the area being treated.\n* The subject is receiving or has received gold therapy.\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 to entering this study.\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': 'NCT04881058', 'briefTitle': 'Post Market Clinical Follow Up Study to Collect Additional Data and Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'officialTitle': 'Post Market Clinical Follow Up Study to Collect Additional Data and Imaging', 'orgStudyIdInfo': {'id': '7012-BDPM-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PicoSure Device', 'description': 'The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.', 'interventionNames': ['Device: RF Non-Invasive Treatment']}], 'interventions': [{'name': 'RF Non-Invasive Treatment', 'type': 'DEVICE', 'description': 'Self-controlled single-arm group using the PicoSure device.', 'armGroupLabels': ['PicoSure Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Plastic Surgery', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}], 'overallOfficials': [{'name': 'Jennifer Civiok', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cynosure, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}