Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02129660
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eugene.bauer@dermira.com', 'phone': '650-421-7202', 'title': 'Eugene A. Bauer, MD, Chief Medical Officer', 'organization': 'Dermira, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 4, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental Exposure to Product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decrease Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypohidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - Week 4/ET', 'description': "HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.\n\n1 (Best), 2, 3, 4 (Worst)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - Week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'PRIMARY', 'title': 'Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-104.20', 'spread': '73.73', 'groupId': 'OG000'}, {'value': '-58.27', 'spread': '31.00', 'groupId': 'OG001'}, {'value': '-105.28', 'spread': '95.83', 'groupId': 'OG002'}, {'value': '-72.69', 'spread': '82.48', 'groupId': 'OG003'}, {'value': '-53.85', 'spread': '70.65', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Week 4', 'description': "Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.", 'unitOfMeasure': 'mg/5 min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'PRIMARY', 'title': 'Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.20', 'spread': '74.87', 'groupId': 'OG000'}, {'value': '-44.37', 'spread': '40.92', 'groupId': 'OG001'}, {'value': '-96.98', 'spread': '103.38', 'groupId': 'OG002'}, {'value': '-66.17', 'spread': '78.96', 'groupId': 'OG003'}, {'value': '-71.06', 'spread': '64.82', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Week 6', 'unitOfMeasure': 'mg/5 min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'OG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'OG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'OG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'OG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - Week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'FG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'FG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'FG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'FG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose 1 of Glycopyrrolate', 'description': 'Dose 1 of glycopyrrolate Topical Wipes'}, {'id': 'BG001', 'title': 'Dose 2 of Glycopyrrolate', 'description': 'Dose 2 of glycopyrrolate Topical Wipes'}, {'id': 'BG002', 'title': 'Dose 1 of Glycopyrronium', 'description': 'Dose 1 of glycopyrronium Topical Wipes'}, {'id': 'BG003', 'title': 'Dose 2 of Glycopyrronium', 'description': 'Dose 2 of glycopyrronium Topical Wipes'}, {'id': 'BG004', 'title': 'Vehicle', 'description': 'Vehicle Topical Wipes'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2015-10-22', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2014-04-30', 'dispFirstSubmitQcDate': '2015-10-22', 'resultsFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2014-04-30', 'dispFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2018-08-28', 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4', 'timeFrame': 'Baseline - Week 4/ET', 'description': "HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.\n\n1 (Best), 2, 3, 4 (Worst)"}, {'measure': 'Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4', 'timeFrame': 'Baseline - Week 4'}, {'measure': 'Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6', 'timeFrame': 'Baseline - Week 6'}, {'measure': 'Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4', 'timeFrame': 'Baseline - Week 4', 'description': "Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min."}, {'measure': 'Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6', 'timeFrame': 'Baseline - Week 6'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4', 'timeFrame': 'Baseline - Week 4'}, {'measure': 'Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6', 'timeFrame': 'Baseline - Week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperhidrosis']}, 'referencesModule': {'references': [{'pmid': '33433785', 'type': 'DERIVED', 'citation': 'Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.', 'detailedDescription': 'This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.\n\nEfficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).\n\nSafety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.\n\nPK blood samples will be taken study subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 years of age or older.\n* Primary, axillary hyperhidrosis of at least 6 months duration.\n* Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.\n* For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.\n* Male or non-pregnant, non-lactating females.\n\nExclusion Criteria:\n\n* Current pregnancy or lactation.\n* Prior surgical procedure for hyperhidrosis.\n* Any prior axillary treatment with an anti-hyperhidrosis medical device\n* Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.\n* Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.\n* Subjects with clinically significant abnormalities in laboratory values.\n* Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.\n* Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.\n* Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.\n* Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit\n* Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.\n* Any previous IV or oral treatment with the study drug.\n* Prior treatment with the topical study drug in a previous trial.\n* Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.\n* Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis\n* Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.\n* Known history of Sjögren's syndrome or Sicca syndrome.\n* History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.\n* Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.\n* Abnormal findings on screening ECG deemed clinically significant by the Investigator.\n* History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia"}, 'identificationModule': {'nctId': 'NCT02129660', 'briefTitle': 'Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Journey Medical Corporation'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis', 'orgStudyIdInfo': {'id': 'DRM04-HH02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 of glycopyrrolate, 2.0% QD', 'description': 'glycopyrrolate Topical Wipes', 'interventionNames': ['Drug: Dose 1 of glycopyrrolate, 2.0% QD']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 of glycopyrrolate, 3.0% QD', 'description': 'glycopyrrolate Topical Wipes', 'interventionNames': ['Drug: Dose 2 of glycopyrrolate, 3.0% QD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 1 of glycopyrronium, 2.5% QD', 'description': 'glycopyrronium Topical Wipes', 'interventionNames': ['Drug: Dose 1 of glycopyrronium, 2.5% QD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 2 of glycopyrronium, 3.75% QD', 'description': 'glycopyrronium Topical Wipes', 'interventionNames': ['Drug: Dose 2 of glycopyrronium, 3.75% QD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle Topical Wipes', 'interventionNames': ['Other: Vehicle']}], 'interventions': [{'name': 'Dose 1 of glycopyrrolate, 2.0% QD', 'type': 'DRUG', 'otherNames': ['DRM04B'], 'description': 'Dose 1 of glycopyrrolate Topical Wipes', 'armGroupLabels': ['Dose 1 of glycopyrrolate, 2.0% QD']}, {'name': 'Dose 2 of glycopyrrolate, 3.0% QD', 'type': 'DRUG', 'otherNames': ['DRM04B'], 'description': 'Dose 2 of glycopyrrolate Topical Wipes', 'armGroupLabels': ['Dose 2 of glycopyrrolate, 3.0% QD']}, {'name': 'Dose 1 of glycopyrronium, 2.5% QD', 'type': 'DRUG', 'otherNames': ['DRM04'], 'description': 'Dose 1 of glycopyrronium Topical Wipes', 'armGroupLabels': ['Dose 1 of glycopyrronium, 2.5% QD']}, {'name': 'Dose 2 of glycopyrronium, 3.75% QD', 'type': 'DRUG', 'otherNames': ['DRM04'], 'description': 'Dose 2 of glycopyrronium Topical Wipes', 'armGroupLabels': ['Dose 2 of glycopyrronium, 3.75% QD']}, {'name': 'Vehicle', 'type': 'OTHER', 'description': 'Vehicle Topical Wipes', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology & Clinical Research Institute', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center For Dermatology Clinical Research', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Kenneth R. Beer MD', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Shideler Clinical Research Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '63122', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Dermatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Haber Dermatology and Cosmetic Surgery', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Rivergate Dermatology Clinical Research Center, PLLC', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center, Inc.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Dermatology Associates', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Women's Clinical Research Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'H2K 4L5', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Innovaderm Research Inc.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Lynne M. Deans, MT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dermira, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Journey Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}