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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.
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.
Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).
Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK blood samples will be taken study subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 of glycopyrrolate, 2.0% QD | Experimental | glycopyrrolate Topical Wipes |
|
| Dose 2 of glycopyrrolate, 3.0% QD | Experimental | glycopyrrolate Topical Wipes |
|
| Dose 1 of glycopyrronium, 2.5% QD | Active Comparator | glycopyrronium Topical Wipes |
|
| Dose 2 of glycopyrronium, 3.75% QD | Active Comparator | glycopyrronium Topical Wipes |
|
| Vehicle | Placebo Comparator | Vehicle Topical Wipes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose 1 of glycopyrrolate, 2.0% QD | Drug | Dose 1 of glycopyrrolate Topical Wipes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 | 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) | Baseline - Week 4/ET |
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 | Baseline - Week 4 | |
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 | Baseline - Week 6 | |
| Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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 |
| Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 | Baseline - Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | Baseline - Week 4 | |
| Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6 |
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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 |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| Center For Dermatology Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33433785 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose 1 of Glycopyrrolate | Dose 1 of glycopyrrolate Topical Wipes |
| FG001 | Dose 2 of Glycopyrrolate | Dose 2 of glycopyrrolate Topical Wipes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dose 2 of glycopyrrolate, 3.0% QD | Drug | Dose 2 of glycopyrrolate Topical Wipes |
|
|
| Dose 1 of glycopyrronium, 2.5% QD | Drug | Dose 1 of glycopyrronium Topical Wipes |
|
|
| Dose 2 of glycopyrronium, 3.75% QD | Drug | Dose 2 of glycopyrronium Topical Wipes |
|
|
| Vehicle | Other | Vehicle Topical Wipes |
|
| Baseline - Week 6 |
| Fremont |
| California |
| 94538 |
| United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| Kenneth R. Beer MD | West Palm Beach | Florida | 33401 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Haber Dermatology and Cosmetic Surgery | Beachwood | Ohio | 44122 | United States |
| Rivergate Dermatology Clinical Research Center, PLLC | Goodlettsville | Tennessee | 37072 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84117 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Dermatology Associates | Seattle | Washington | 98101 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Innovaderm Research Inc. | Montreal | H2K 4L5 | Canada |
| FG002 | Dose 1 of Glycopyrronium | Dose 1 of glycopyrronium Topical Wipes |
| FG003 | Dose 2 of Glycopyrronium | Dose 2 of glycopyrronium Topical Wipes |
| FG004 | Vehicle | Vehicle Topical Wipes |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose 1 of Glycopyrrolate | Dose 1 of glycopyrrolate Topical Wipes |
| BG001 | Dose 2 of Glycopyrrolate | Dose 2 of glycopyrrolate Topical Wipes |
| BG002 | Dose 1 of Glycopyrronium | Dose 1 of glycopyrronium Topical Wipes |
| BG003 | Dose 2 of Glycopyrronium | Dose 2 of glycopyrronium Topical Wipes |
| BG004 | Vehicle | Vehicle Topical Wipes |
| BG005 | Total | Total of all reporting groups |
| 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 |
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| 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 | Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 | 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 | Count of Participants | Participants | Baseline - Week 4/ET |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 | Participant | Posted | Count of Participants | Participants | Baseline - Week 4 |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 | Participant | Posted | Count of Participants | Participants | Baseline - Week 6 |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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 - Week 4 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 | Participant | Posted | Mean | Standard Deviation | mg/5 min | Baseline - Week 6 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | Participant | Posted | Count of Participants | Participants | Baseline - Week 4 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6 | Participant | Posted | Count of Participants | Participants | Baseline - Week 6 |
|
6 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 | Dose 1 of Glycopyrrolate | Dose 1 of glycopyrrolate Topical Wipes | 0 | 21 | 0 | 21 | 4 | 21 |
| EG001 | Dose 2 of Glycopyrrolate | Dose 2 of glycopyrrolate Topical Wipes | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | Dose 1 of Glycopyrronium | Dose 1 of glycopyrronium Topical Wipes | 0 | 22 | 0 | 22 | 11 | 22 |
| EG003 | Dose 2 of Glycopyrronium | Dose 2 of glycopyrronium Topical Wipes | 0 | 20 | 0 | 20 | 10 | 20 |
| EG004 | Vehicle | Vehicle Topical Wipes | 0 | 21 | 0 | 21 | 6 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mydriasis | Eye disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Application Site Pain | General disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Accidental Exposure to Product | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Decrease Appetite | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Drug Interaction | General disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypohidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Injection Site Bruising | General disorders | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Panic attack | Psychiatric disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tongue disorder | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Vision blurred | 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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| Between 18 and 65 years |
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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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| OG004 |
| Vehicle |
Vehicle Topical Wipes |
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