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This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrronium | Experimental | Glycopyrronium Topical Wipes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium Topical Wipes | Drug | Glycopyrronium Topical Wipes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | 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. | Day 1 - Week 44 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne Deans, MT | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Medical Research Group LLC | Mobile | Alabama | 36608 | United States | ||
| Northwest Arkansas Clinical Trials Center, PLLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31111409 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycopyrronium | Glycopyrronium Topical Wipes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
| Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | 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. | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET | The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired. | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Colorado Medical Research Center, Inc | Denver | Colorado | 80210 | 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, MD | North Miami Beach | Florida | 33162 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Prairie Health and Wellness | Wichita | Kansas | 67206 | United States |
| Lawrence J. Green M.D., LLC | Rockville | Maryland | 20850 | United States |
| Zel Skin & Laser Specialist | Edina | Minnesota | 55424 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| St. Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106-5239 | 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 |
| Dermatology and Laser Center of Charleston, PA | Charleston | Pennsylvania | 29414 | United States |
| Rivergate Dermatology Research Center, PLLC | Goodlettsville | Tennessee | 37072 | United States |
| Clinical Research Associates, Inc | Nashville | Tennessee | 37203 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| The University of Texas Dermatology Clinical Research Center | Houston | Texas | 77030 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78860 | United States |
| ACRC Trials | Plano | Texas | 75024 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84117 | United States |
| Jordan Valley Dermatology Center, LLC | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Dermatology Associates | Seattle | Washington | 98101 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité | 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 |
| Gemeinschaftspraxis Weber & Cranic | Schweinfurt | 97421 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycopyrronium | Glycopyrronium Topical Wipes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | 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. | Participant | Posted | Number | Adverse Events and Local Skin Reactions | Day 1 - Week 44 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Mean | Standard Deviation | mg/5 min | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | 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 | participants | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET | The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired. | Participant | Posted | Mean | Standard Deviation | scores on a scale | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET |
|
|
up to 45 weeks
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 Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes | 0 | 550 | 7 | 550 | 178 | 550 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Infectious colitis | Infections and infestations | Systematic Assessment |
| ||
| Affective disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| ||
| Mydriasis | Eye disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Application Site Pain | General disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| 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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| Unknown or Not Reported |
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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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| Title | Measurements |
|---|---|
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| Mild LSRs |
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| Moderate LSRs |
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| Severe LSRs |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 3 - point improvement |
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| 2 - point improvement |
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| 1 - point improvement |
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| no improvement |
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