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The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.
Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.
Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK samples will be taken from 20 to 30 subjects participating in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glycopyrrolate, 1.0% | Experimental | glycopyrrolate Topical Wipes, 1.0% |
|
| glycopyrrolate, 2.0% | Experimental | glycopyrrolate Topical Wipes, 2.0% |
|
| glycopyrrolate, 3.0% | Experimental | glycopyrrolate Topical Wipes, 3.0% |
|
| glycopyrrolate, 4.0% | Experimental | glycopyrrolate Topical Wipes, 4.0% |
|
| Vehicle | Placebo Comparator | Vehicle Topical Wipes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycopyrrolate, 1.0% | Drug | glycopyrrolate Topical Wipes, 1.0% |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 | Baseline - Week 4 | |
| Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 | Baseline - 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 |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Gary M. Petrus, MD, PA |
| 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 | Glycopyrrolate, 1.0% | glycopyrrolate Topical Wipes, 1.0% |
| FG001 | Glycopyrrolate, 2.0% | glycopyrrolate Topical Wipes, 2.0% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| glycopyrrolate, 2.0% | Drug | glycopyrrolate Topical Wipes, 2.0% |
|
|
| glycopyrrolate, 3.0% | Drug | glycopyrrolate Topical Wipes, 3.0% |
|
|
| glycopyrrolate, 4.0% | Drug | glycopyrrolate Topical Wipes, 4.0% |
|
|
| Vehicle | Other | Vehicle Topical Wipes |
|
|
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 | Baseline - Week 6 |
| Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4 | The 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 - Week 4 |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| Center For Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Florida Academic Dermatology Center | Miami | Florida | 33136 | United States |
| Kenneth R. Beer, MD, PA | West Palm Beach | Florida | 33401 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| The Dermatology Group, PC | Verona | New Jersey | 07044 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84117 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Westend Dermatology Associates | Richmond | Virginia | 23233 | 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 |
| FG002 | Glycopyrrolate, 3.0% | glycopyrrolate Topical Wipes, 3.0% |
| FG003 | Glycopyrrolate, 4.0% | glycopyrrolate Topical Wipes, 4.0% |
| FG004 | Vehicle | Vehicle Topical Wipes |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycopyrrolate, 1.0% | glycopyrrolate Topical Wipes, 1.0% |
| BG001 | Glycopyrrolate, 2.0% | glycopyrrolate Topical Wipes, 2.0% |
| BG002 | Glycopyrrolate, 3.0% | glycopyrrolate Topical Wipes, 3.0% |
| BG003 | Glycopyrrolate, 4.0% | glycopyrrolate Topical Wipes, 4.0% |
| 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 |
| ||||||||||||||||
| 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 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 | Participant | Posted | Count of Participants | Participants | Baseline - Week 6 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4 | The 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 - Week 4 |
|
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 | Glycopyrrolate, 1.0% | glycopyrrolate Topical Wipes, 1.0% | 0 | 36 | 0 | 36 | 9 | 36 |
| EG001 | Glycopyrrolate, 2.0% | glycopyrrolate Topical Wipes, 2.0% | 0 | 39 | 0 | 39 | 17 | 39 |
| EG002 | Glycopyrrolate, 3.0% | glycopyrrolate Topical Wipes, 3.0% | 0 | 40 | 1 | 40 | 18 | 40 |
| EG003 | Glycopyrrolate, 4.0% | glycopyrrolate Topical Wipes, 4.0% | 0 | 40 | 0 | 40 | 23 | 40 |
| EG004 | Vehicle | Vehicle Topical Wipes | 0 | 39 | 0 | 39 | 10 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Nevus of the left upper abdomen |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mydriasis | Eye disorders | Systematic Assessment | Mydriasis |
| |
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypohidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Application Site Folliculitis | Infections and infestations | 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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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 |
| Vehicle |
Vehicle Topical Wipes |
|
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| Participants |
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| Participants |
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| Vehicle |
Vehicle Topical Wipes |
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