Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT04210258
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2019-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-27', 'studyFirstSubmitDate': '2019-12-17', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder rate for marionette lines after treatment with Etermis 3 based on the blinded Investigator\'s opinion on the Merz Aesthetics Scale "Marionette lines- At Rest"', 'timeFrame': 'Baseline to month 6-7'}, {'measure': 'Responder rate for lips after treatment with Etermis 3 based on the blinded Investigator\'s opinion on the Merz Aesthetics Scale "Upper and lower lip fullness - At Rest"', 'timeFrame': 'Baseline to month 3-4'}, {'measure': 'Responder rate for NLFs after treatment with Etermis 4 based on the blinded Investigator\'s opinion on the Merz Aesthetics Scale "Nasolabial folds- At Rest"', 'timeFrame': 'Baseline to month 6-7'}, {'measure': 'Responder rate for marionette lines after treatment with Etermis 4 based on the blinded Investigator\'s opinion on the Merz Aesthetics Scale "Marionette lines- At Rest"', 'timeFrame': 'Baseline to month 6-7'}, {'measure': 'Responder rate for lips after treatment with Etermis 4 based on the blinded Investigator\'s opinion on the Merz Aesthetics Scale "Upper and lower lip fullness - At Rest"', 'timeFrame': 'Baseline to month 3-4'}], 'secondaryOutcomes': [{'measure': 'Change of blinded Investigator\'s assessment of marionette lines, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to the Merz Aesthetics Scale "Marionette lines - At Rest', 'timeFrame': 'Baseline up to month 12-13'}, {'measure': 'Change of blinded Investigator\'s assessment of lip volume, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to Merz Aesthetics Scale "Upper and Lower lip fullness - At Rest"', 'timeFrame': 'Baseline up to month 12-13'}, {'measure': 'Change of blinded Investigator\'s assessment of nasolabial folds, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to the Merz Aesthetics Scale "Nasolabial folds - At Rest"', 'timeFrame': 'Baseline up to month 12-13'}, {'measure': "Subject's satisfaction on the global impression of changes scale (GICS) from D0 pre-injection photos to M1 visit pre-optional touch-ups, M2 visit if applicable, M3/M4, M6/M7 visit, M9/M10 visit and to M12/M13 visit.", 'timeFrame': 'Baseline up to month 12-13'}, {'measure': "Blinded Investigator's global opinion on clinical performance on the global aesthetic improvement scale (GAIS) from D0 pre-injection photos to M1 visit pre-optional touch-ups, M2 visit if applicable, M3/M4, M6/M7 visit, M9/M10 visit and to M12/M13 visit.", 'timeFrame': 'Baseline up to month 12-13'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Correction of Facial Wrinkles/Folds', 'Facial Volume Enhancement']}, 'descriptionModule': {'briefSummary': 'To confirm the clinical performance of Etermis 3 and Etermis 4 based on the blinded investigator´s assessments on the respective Merz Aesthetics Scales from day 0 (D0) pre-injection to month 6/7 (depending on touch up) visit for nasolabial folds and marionette lines and from D0 pre-injection to month 3/4 (depending on touch up) visit for upper and lower lip fullness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male and female subjects seeking hyaluronic acid dermal filler treatment to redefine/volumize/correct at least two of the indicated facial areas (NLFs, marionette lines, upper and lower lips)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects seeking hyaluronic acid dermal filler treatment to redefine/volumize/correct at least two of the indicated facial areas:\n\n * Nasolabial folds\n * Marionette lines\n * Upper and lower lip fullness\n\nExclusion Criteria:\n\n* Subjects that have already been injected with non-resorbable filler, or that have recently been treated with any dermal filler in the region to be treated in the study\n* Subjects with known sensitivity to hyaluronic acid-based products'}, 'identificationModule': {'nctId': 'NCT04210258', 'acronym': 'POMET', 'briefTitle': 'Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'Open Label Multicenter Evaluator-blinded Post-market Clinical Follow-up (PMCF) Study to Confirm Performance and Safety of Etermis 3 and 4 in the Treatment of Moderate and Severe Wrinkles/Folds as Well as Facial Volume Enhancement', 'orgStudyIdInfo': {'id': 'M900991001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etermis 3', 'type': 'DEVICE', 'description': 'Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling facial moderate wrinkles (marionette lines) and/or to increase lip volume'}, {'name': 'Etermis 4', 'type': 'DEVICE', 'description': 'Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling deep and severe volume loss (nasolabial folds and/or marionette lines) and/or to increase lip volume'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490099', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490095', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22609', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490345', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '34121', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490309', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '80333', 'city': 'München', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490368', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Merz Investigational Site #0490362', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceuticals GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}