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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002053-35 | EudraCT Number |
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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.
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.
Safety will be assessed through lab tests, ECG, physical exams and vital signs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glycopyrronium | Experimental | glycopyrronium Topical Wipes |
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| Vehicle | Placebo Comparator | glycopyrronium Topical Wipes, Vehicle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycopyrronium Topical Wipes | Drug | Topical wipes containing glycopyrronium |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
| From Baseline to Week 4 |
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | 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. | Baseline - Week 4 |
| Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | From Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | 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. | From Baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne M Deans, MT | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Clinical Trials Center, PLLC | Rogers | Arkansas | 72758 | United States | ||
| Dermatology Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32147881 | Derived | 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. | |
| 31111409 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycopyrronium | glycopyrronium Topical Wipes |
| FG001 | Vehicle | glycopyrronium Topical Wipes, Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle | Other | Vehicle (placebo) topical wipes |
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| Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | From Baseline to Week 4 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80210 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| Lawrence J Green, MD LLC | Rockville | Maryland | 20850 | United States |
| Zel Skin & Laser Specialist | Edina | Minnesota | 55424 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Clinical Studies Group, LLC | Henderson | Nevada | 89044 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Schweiger Dermatology Group | New York | New York | 10022 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| The University of Texas Dermatology Clinical Research Center | Houston | Texas | 77030 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84117 | United States |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | United States |
| Dermatology Associates | Seattle | Washington | 98101 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| 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. |
| 30378087 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycopyrronium | glycopyrronium Topical Wipes |
| BG001 | Vehicle | glycopyrronium Topical Wipes, Vehicle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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:
| Participant | Posted | Number | percent of subjects | From Baseline to Week 4 |
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| Primary | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | 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. | Participant | Posted | Least Squares Mean | Standard Deviation | mg/5 min | Baseline - Week 4 |
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| Primary | Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | Participant | Posted | Median | Inter-Quartile Range | mg/5 min | From Baseline to Week 4 |
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| Secondary | Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | 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. | Participant | Posted | Number | percent of subjects | From Baseline to Week 4 |
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| Secondary | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | Participant | Posted | Number | percent of subjects | From Baseline to Week 4 |
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Up to 35 days
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glycopyrronium | glycopyrronium Topical Wipes | 0 | 232 | 1 | 232 | 101 | 232 |
| EG001 | Vehicle | glycopyrronium Topical Wipes, Vehicle | 0 | 118 | 0 | 118 | 22 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Application site pain | General disorders | Systematic Assessment |
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| Mydriasis | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugene A. Bauer, MD, Chief Medical Officer | Dermira, Inc. | 650-421-7202 | eugene.bauer@dermira.com |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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