Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:34 AM
Study NCT ID:
NCT01297634
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2011-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Area', 'timeFrame': 'Change from baseline at day 30', 'description': 'Radial area (cephalic, lateral, medial and caudal points) of physioelectric activity of the frontal muscle, measured with electromyography (EMG).\n\nClinical and Photographical register evaluation of the dynamical wrinkles in the treatment area.'}], 'secondaryOutcomes': [{'measure': 'Complete Treatment Phase', 'timeFrame': 'Day 30', 'description': 'Quantity of Botulinum Toxin used in every subject to aim to complete the treatment to the rest of the frontal area, based on the results of the primary outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Botulinum toxin type A', 'Hyperfunctional forehead lines', 'Randomized controlled trial', 'Double-blinded trial', 'Electromyogram (EMG)', 'Electromyographic activity', 'Frontal Area'], 'conditions': ['Wrinkles']}, 'descriptionModule': {'briefSummary': 'This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the drug. A basal line control and After the application control will be made, and the investigators will evaluate the drug effects, based on clinical aspects, photographic registers and through electromyography exam (EMG).\n\nConsidering the results of our investigation, the investigators may propose a pattern of application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have indication for aesthetic treatment of the frontal dynamic wrinkles, in maximal contraction of the frontal muscle.\n* Availability and understanding of the patient, for complete all the steps throughout the duration of the study.\n* Medical history and physical examination compatible with the study.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Subjects with previous forehead face lifting or blepharoplasty surgery.\n* Previous use of Botulinum toxin in the last 6 months.\n* Forehead or eyelid asymmetry.\n* Subjects with infections on site of injection or inflammatory skin diseases.\n* Subjects with hypersensitivity to any component of the formulation, including albumin.\n* Subjects with neuropathic or neuromuscular diseases.\n* Subjects using aminoglycosides, penicillamine antibiotics, quinine and Ca2+ channel blockers.\n* Subjects with pregnancy and lactation, or that planning become pregnant during the time of the study.\n* Subjects with dimorphism or others psychological disorders.'}, 'identificationModule': {'nctId': 'NCT01297634', 'briefTitle': 'Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Ivo Pitanguy Institute'}, 'officialTitle': 'Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.', 'orgStudyIdInfo': {'id': '191622'}, 'secondaryIdInfos': [{'id': '396936', 'type': 'OTHER', 'domain': 'CEP00/11'}, {'id': 'CEP001/11', 'type': 'OTHER', 'domain': 'Research Ethics Committee, Brazil'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Botulinum Toxin Type-A 1U', 'interventionNames': ['Drug: Botulinum Toxin Type-A (day 0)']}, {'type': 'OTHER', 'label': 'Botulinum Toxin Type-A 2U', 'interventionNames': ['Drug: Botulinum Toxin Type-A (day 0)']}, {'type': 'OTHER', 'label': 'Botulinum Toxin Type-A 3U', 'interventionNames': ['Drug: Botulinum Toxin Type-A (day 0)']}], 'interventions': [{'name': 'Botulinum Toxin Type-A (day 0)', 'type': 'DRUG', 'description': '* Botulinum Toxin Type-A 1 unit. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n* Botulinum Toxin Type-A 1 unit. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n* Botulinum Toxin Type-A 1 unit. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.', 'armGroupLabels': ['Botulinum Toxin Type-A 1U']}, {'name': 'Botulinum Toxin Type-A (day 0)', 'type': 'DRUG', 'description': '* Botulinum Toxin Type-A 2 Units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n* Botulinum Toxin Type-A 2 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n* Botulinum Toxin Type-A 2 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.', 'armGroupLabels': ['Botulinum Toxin Type-A 2U']}, {'name': 'Botulinum Toxin Type-A (day 0)', 'type': 'DRUG', 'description': 'Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n\n* Botulinum Toxin Type-A 3 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.\n* Botulinum Toxin Type-A 3 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.', 'armGroupLabels': ['Botulinum Toxin Type-A 3U']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22280-020', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Ivo Pitanguy Institute', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivo Pitanguy Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Plastic Surgeon', 'investigatorFullName': 'Armando Iniguez MD', 'investigatorAffiliation': 'Ivo Pitanguy Institute'}}}}