Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT02530294
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of 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': 'Up to 35 days', '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': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 101, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 22, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 4', 'description': 'The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:\n\n1. During the past 24 hours, did you have any underarm sweating? (Yes or No)\n2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)\n3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)\n4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)', 'unitOfMeasure': 'percent of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'PRIMARY', 'title': 'Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-115.43', 'spread': '66.511', 'groupId': 'OG000'}, {'value': '-81.20', 'spread': '66.714', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Ranked ANCOVA'}], 'paramType': 'LEAST_SQUARES_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': 'Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '-78.77', 'groupId': 'OG000', 'lowerLimit': '-143.97', 'upperLimit': '-45.48'}, {'value': '-57.94', 'groupId': 'OG001', 'lowerLimit': '-121.85', 'upperLimit': '-21.16'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Ranked ANCOVA'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 4', 'unitOfMeasure': 'mg/5 min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 4', 'description': "Hyperhidrosis Disease Severity Scale (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.", 'unitOfMeasure': 'percent of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 4', 'unitOfMeasure': 'percent of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glycopyrronium', 'description': 'glycopyrronium Topical Wipes'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2017-03-30', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2015-08-19', 'dispFirstSubmitQcDate': '2017-03-30', 'resultsFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2015-08-20', 'dispFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-20', 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4', 'timeFrame': 'From Baseline to Week 4', 'description': 'The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:\n\n1. During the past 24 hours, did you have any underarm sweating? (Yes or No)\n2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)\n3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)\n4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)'}, {'measure': 'Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at 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': 'Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4', 'timeFrame': 'From Baseline to Week 4'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4', 'timeFrame': 'From Baseline to Week 4', 'description': "Hyperhidrosis Disease Severity Scale (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."}, {'measure': 'Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4', 'timeFrame': 'From Baseline to Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperhidrosis']}, 'referencesModule': {'references': [{'pmid': '32147881', 'type': 'DERIVED', 'citation': 'Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.'}, {'pmid': '31111409', 'type': 'DERIVED', 'citation': 'Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.'}, {'pmid': '30378087', 'type': 'DERIVED', 'citation': 'Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.', 'detailedDescription': 'This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.\n\nSafety will be assessed through lab tests, ECG, physical exams and vital signs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ≥ 9 years of age.\n* Primary, axillary hyperhidrosis of at least 6 months duration.\n* Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline.\n* Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline.\n* Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically.\n\nExclusion Criteria:\n\n* Prior surgical procedure for hyperhidrosis.\n* Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).\n* Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.\n* Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.\n* Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.\n* Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.\n* Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.\n* Other treatment with glycopyrrolate within 4 weeks prior to Baseline.\n* Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.\n* 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* History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.\n* Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study."}, 'identificationModule': {'nctId': 'NCT02530294', 'briefTitle': 'Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Journey Medical Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis', 'orgStudyIdInfo': {'id': 'DRM04-HH05'}, 'secondaryIdInfos': [{'id': '2015-002053-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glycopyrronium', 'description': 'glycopyrronium Topical Wipes', 'interventionNames': ['Drug: glycopyrronium Topical Wipes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'glycopyrronium Topical Wipes, Vehicle', 'interventionNames': ['Other: Vehicle']}], 'interventions': [{'name': 'glycopyrronium Topical Wipes', 'type': 'DRUG', 'otherNames': ['DRM04'], 'description': 'Topical wipes containing glycopyrronium', 'armGroupLabels': ['glycopyrronium']}, {'name': 'Vehicle', 'type': 'OTHER', 'description': 'Vehicle (placebo) topical wipes', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Clinical Trials Center, PLLC', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Medical Research Center, Inc.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Shideler Clinical Research Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Lawrence J Green, MD LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, 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