Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-03-11 @ 8:47 PM
Study NCT ID:
NCT02565732
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2016-08-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2015-09-29', 'dispFirstSubmitQcDate': '2016-08-02', 'studyFirstSubmitQcDate': '2015-09-29', 'dispFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperhidrosis Disease Severity Scale (HDSS)', 'timeFrame': 'Week 4', 'description': 'Improvement at follow-up in the experimental groups compared to the placebo group'}, {'measure': 'Gravimetry', 'timeFrame': 'Week 4', 'description': 'The amount of sweat measured gravimetrically'}], 'secondaryOutcomes': [{'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Week 4'}]}, 'conditionsModule': {'conditions': ['Hyperhidrosis']}, 'descriptionModule': {'briefSummary': 'This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary axillary hyperhidrosis\n* Female or male, 18 years of age or older in good general health\n* Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline\n* Axillary sweat production of at least 50 mg/5 min measured gravimetrically\n\nExclusion Criteria:\n\n* Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis\n* Muscle weakness or paralysis, particularly in the upper extremities\n* Active skin disease or irritation or disrupted barrier at the treatment area\n* Undergone any procedures which may affect the axillary areas\n* Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months\n* Any prior axillary use of an anti-hyperhidrosis medical device\n* If menopausal had symptoms of menopause such as sweating or flushing within the last year'}, 'identificationModule': {'nctId': 'NCT02565732', 'briefTitle': 'Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'RT001-CL045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose A', 'description': 'Botulinum toxin type A', 'interventionNames': ['Biological: Botulinum toxin type A']}, {'type': 'EXPERIMENTAL', 'label': 'Dose B', 'description': 'Botulinum toxin type A', 'interventionNames': ['Biological: Botulinum toxin type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose C', 'description': 'Placebo comparator', 'interventionNames': ['Biological: Placebo comparator']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'BIOLOGICAL', 'description': 'Botulinum toxin type A, Dose A, Topical', 'armGroupLabels': ['Dose A']}, {'name': 'Botulinum toxin type A', 'type': 'BIOLOGICAL', 'description': 'Botulinum toxin type A, Dose B, Topical', 'armGroupLabels': ['Dose B']}, {'name': 'Placebo comparator', 'type': 'BIOLOGICAL', 'description': 'Placebo, Dose C, Topical', 'armGroupLabels': ['Dose C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}