Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00429520
Status:
COMPLETED
Last Update Posted:
2008-02-07
First Post:
2007-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2008-02-05', 'studyFirstSubmitDate': '2007-01-30', 'studyFirstSubmitQcDate': '2007-01-30', 'lastUpdatePostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity rating scale assessed by independent rater'}]}, 'conditionsModule': {'conditions': ['Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* main inclusion criteria: severity rating scale grade 3 or 4\n\nExclusion Criteria:\n\n* main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry'}, 'identificationModule': {'nctId': 'NCT00429520', 'briefTitle': 'Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)', 'orgStudyIdInfo': {'id': 'MRZ 90026-0423/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hyaluronic acid filler/IMD1 basic', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60318', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Merz Pharmaceuticals', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Johannes Reinmüller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik am Sonnenberg, Wiesbaden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}}}}