Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-20 @ 3:55 AM
Study NCT ID:
NCT02019004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-31
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629279', 'term': 'onabotulinum toxin A'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C545476', 'term': 'incobotulinumtoxinA'}], '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin', 'timeFrame': 'At baseline and at 6 months', 'description': 'Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is:\n\n0: no facial wrinkles\n\n1. mild facial wrinkles\n2. moderate facial wrinkles\n3. severe facial wrinkling'}, {'measure': 'Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin', 'timeFrame': 'At baseline and at 6 months', 'description': 'Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is:\n\n0: no wrinkles\n\n1. minimal wrinkles\n2. mild wrinkles\n3. moderate wrinkles\n4. severe wrinkles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkles']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.', 'detailedDescription': 'Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction.\n\nThis study is a pilot study designed to determine feasibility of these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Females and males\n2. In good health\n3. Is 20-65 years of age\n4. Has static and moderate dynamic forehead/glabellar wrinkles\n5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff\n\nExclusion Criteria:\n\n1. Pregnant or lactating\n2. Younger than 20 or older than 65 years of age\n3. Has received the following treatments in the forehead or glabellar region:\n\n 1. botulinum toxin injections in the past 6 months\n 2. ablative laser procedure in the past 6 months\n 3. radiofrequency device treatment in the past 6 months\n 4. ultrasound device treatment in the past 6 months\n 5. medium to deep chemical peel in the past 6 months\n 6. temporary soft tissue augmentation material in the area to be treated in the past year\n 7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years\n 8. permanent soft tissue augmentation material in the area to be treated\n4. Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.\n5. Is planning to use tretinoin or retinoic acid in the next 6 months\n6. Has an active infection in the forehead or glabellar region (excluding mild acne)\n7. Is allergic to cow's milk protein\n8. Is allergic to albumin\n9. Taking aminoglycoside\n10. Is currently using anticoagulation therapy\n11. Has a history of bleeding disorders\n12. Has a mental illness\n13. Unable to understand the protocol or to give informed consent"}, 'identificationModule': {'nctId': 'NCT02019004', 'briefTitle': 'A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial', 'orgStudyIdInfo': {'id': 'STU83962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Onabotulinum Toxin A', 'description': 'One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.', 'interventionNames': ['Drug: Onabotulinum Toxin A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incobotulinum Toxin A', 'description': 'The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.', 'interventionNames': ['Drug: Incobotulinum Toxin A']}], 'interventions': [{'name': 'Onabotulinum Toxin A', 'type': 'DRUG', 'otherNames': ['Botox'], 'armGroupLabels': ['Onabotulinum Toxin A']}, {'name': 'Incobotulinum Toxin A', 'type': 'DRUG', 'otherNames': ['Xeomin'], 'armGroupLabels': ['Incobotulinum Toxin A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Murad Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation', 'investigatorFullName': 'Murad Alam', 'investigatorAffiliation': 'Northwestern University'}}}}