Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-24 @ 4:12 AM
Study NCT ID:
NCT02942303
Status:
UNKNOWN
Last Update Posted:
2017-05-15
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542869', 'term': 'abobotulinumtoxinA'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective assessment', 'timeFrame': '15 days post treatment', 'description': 'Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, medial limbus, mid pupil, lateral limbus, lateral sclera, and most lateral eyebrow.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '15 days post treatment', 'description': 'Patient satisfaction will be determined by a questionnaire completed at 15 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:\n\n1. Very Satisfied\n2. Satisfied\n3. Dissatisfied\n4. Very Dissatisfied.'}]}, 'conditionsModule': {'keywords': ['Botulinum Toxin, Rejuvenation, Brow lift, Eyebrow.'], 'conditions': ['Brow Lifting']}, 'referencesModule': {'references': [{'pmid': '29280866', 'type': 'DERIVED', 'citation': 'El-Khoury JS, Jabbour SF, Awaida CJ, Rayess YA, Kechichian EG, Nasr MW. The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial. Plast Reconstr Surg. 2018 Jan;141(1):75-78. doi: 10.1097/PRS.0000000000003919.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '28 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques\n\nExclusion Criteria:\n\n* Patients with previous periorbital/forehead surgery\n* Patients who plucked the upper eyebrow margin\n* Patients with eyebrow tatoos\n* Patients with upper face botulinum toxin injection in the past 12 months\n* Patients with resorbable upper face fillers injection in the past 12 months\n* Patients with previous permanent upper face fillers injection\n* Pregnant patients\n* Lactating patients\n* Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)\n* Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)\n* Patients with sensitivity to botulinum toxin or human albumin'}, 'identificationModule': {'nctId': 'NCT02942303', 'briefTitle': 'The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'St Joseph University, Beirut, Lebanon'}, 'orgStudyIdInfo': {'id': 'USJ-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Technique 1: Lateral orbicularis injections', 'description': '5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim.', 'interventionNames': ['Drug: Dysport', 'Procedure: lateral orbicularis injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Technique 2: Lateral orbicularis and Corrugator injections', 'description': '5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow', 'interventionNames': ['Drug: Dysport', 'Procedure: Lateral orbicularis + corrugator injection']}], 'interventions': [{'name': 'Dysport', 'type': 'DRUG', 'otherNames': ['abobotulinumtoxineA'], 'armGroupLabels': ['2. Technique 2: Lateral orbicularis and Corrugator injections', 'Technique 1: Lateral orbicularis injections']}, {'name': 'lateral orbicularis injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Technique 1: Lateral orbicularis injections']}, {'name': 'Lateral orbicularis + corrugator injection', 'type': 'PROCEDURE', 'armGroupLabels': ['2. Technique 2: Lateral orbicularis and Corrugator injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00961', 'city': 'Beirut', 'state': 'Aschrafieh', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'samer jabbour, M.D.', 'role': 'CONTACT', 'email': 'samermed@gmail.com', 'phone': '009613416234'}], 'facility': 'Hotel Dieu De France', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Joseph University, Beirut, Lebanon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'samer jabbour', 'investigatorAffiliation': 'St Joseph University, Beirut, Lebanon'}}}}