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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002052-27 | 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 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. | From Baseline to Week 4 |
| Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | From Baseline to Week 4 | |
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data | Baseline - 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. 1 (Best), 2, 3, 4 (Worst) | 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 |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| California Dermatology & Clinical Research Institute |
| 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 |
| Encinitas |
| California |
| 92024 |
| United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | United States |
| Study Protocol, Inc. | Boynton Beach | Florida | 33437 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Tory Sullivan, M.D., P.A. | North Miami Beach | Florida | 33162 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Prairie Health and Wellness | Wichita | Kansas | 67226 | United States |
| St. Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Dermatology and Laser Center | Charleston | South Carolina | 29414 | United States |
| Rivergate Dermatology Clinical Research Center, PLLC | Goodlettsville | Tennessee | 37072 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| J&S Studies | College Station | Texas | 77845 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78860 | United States |
| ACRC Trials / Innovative Dermatology | Plano | Texas | 75024 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Charlottesville Dermatology Research Center | Charlottesville | Virginia | 22911 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite | Berlin | 10117 | Germany |
| Pro DERMA im Hautzentrum Dulmen | Dülmen | 48249 | Germany |
| Medical Practice and Derma Study Center Friedrichshafen GmbH | Friedrichshafen | 88045 | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | 07548 | Germany |
| Hautarztpraxis | Glückstadt | 25348 | Germany |
| Tagesklinik DermaKiel | Kiel | 24148 | Germany |
| Dermatolosche Gemeinschaftspraxis | Mahlow | 15831 | Germany |
| Hautarztpraxis | Pinneberg | 25421 | Germany |
| Gemeinschaftspraxis Weber & Cranic | Schweinfurt | 97421 | Germany |
| Hautarztpraxis | Stuttgart | 70499 | Germany |
| 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 | ||||||||||||
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| 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 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 | From Baseline to 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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| Primary | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data | Participant | Posted | Least Squares Mean | Standard Deviation | mg/5 min | Baseline - 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. 1 (Best), 2, 3, 4 (Worst) | 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 | 227 | 1 | 227 | 68 | 227 |
| EG001 | Vehicle | glycopyrronium Topical Wipes, Vehicle | 0 | 114 | 0 | 114 | 16 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unilateral mydriasis | Eye 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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| Application Site Pain | General disorders | Systematic Assessment |
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| Application Site Pruritis | General disorders | Systematic Assessment |
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| Mydriasis | Eye 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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