Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 10:27 PM
Study NCT ID:
NCT01308593
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2011-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brow Enhancement Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant satisfaction with combined injection with Botox and Juvederm XC', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brow Ptosis']}, 'descriptionModule': {'briefSummary': 'Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n\nExclusion Criteria:\n\n* Persons who have not had Botox for months.\n* Women who are pregnant, breastfeeding, or trying to get pregnant.'}, 'identificationModule': {'nctId': 'NCT01308593', 'briefTitle': 'Brow Enhancement Study', 'organization': {'class': 'OTHER', 'fullName': 'Skin Care and Laser Physicians of Beverly Hills'}, 'officialTitle': 'Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction', 'orgStudyIdInfo': {'id': 'Brow Study 25856/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Juvederm XC', 'description': 'Juvederm XC', 'interventionNames': ['Device: Juvederm XC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox', 'description': 'Medication used to block neuromuscular transmission', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Juvederm XC', 'type': 'DEVICE', 'description': 'Filler', 'armGroupLabels': ['Juvederm XC']}, {'name': 'Botox', 'type': 'DRUG', 'description': '26 units dosed one time', 'armGroupLabels': ['Botox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care and Laser Physicians of Beverly Hills', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skin Care and Laser Physicians of Beverly Hills', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Derek H. Jones, M.D.', 'investigatorAffiliation': 'Skin Care and Laser Physicians of Beverly Hills'}}}}