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The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Active | Active Comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
|
| Group 1 Vehicle | Placebo Comparator | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
|
| Group 2 Active | Active Comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
|
| Group 2 Vehicle | Placebo Comparator | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
|
| Group 3 Active | Active Comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes |
|
| Group 3 Vehicle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium cloth, 2.4% | Drug | Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)]. | Baseline, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 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 (better), 2, 3, 4 (worse) | Baseline, Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Doherty | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| Colorado Medical Research Center, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| FG001 | Group 1 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| FG002 | Group 2 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| FG003 | Group 2 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| FG004 | Group 3 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes |
| FG005 | Group 3 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes |
| FG006 | Group 4 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes |
| FG007 | Group 4 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| BG001 | Group 1 Vehicle | Vehicle applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)]. | Intent to Treat Population | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2 |
|
Baseline through Week 2
All subjects who are randomized and receive at least one confirmed dose of study drug will be included in the safety population.
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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 | Group 1 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Adajar | Dermira, Inc | 650-421-2919 | jordan.adajar@dermira.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2018 | Jun 16, 2020 | Prot_SAP_000.pdf |
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| Placebo Comparator |
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes |
|
| Group 4 Active | Active Comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes |
|
| Group 4 Vehicle | Placebo Comparator | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes |
|
| Vehicle | Drug | Pre-saturated 100% polypropylene, nonwoven, fabric cloth |
|
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2 | Baseline, Week 2 |
| Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production | Baseline, Week 2 |
| Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group | Baseline, Week 2 |
| Denver |
| Colorado |
| 80210 |
| United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63122 | United States |
| Innovative Dermatology/ ACRC Trials | Plano | Texas | 75024 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| BG002 | Group 2 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| BG003 | Group 2 Vehicle | Vehicle applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| BG004 | Group 3 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes |
| BG005 | Group 3 Vehicle | Vehicle applied to the hands once daily for 14 days: 15 minutes |
| BG006 | Group 4 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes |
| BG007 | Group 4 Vehicle | Vehicle applied to the hands once daily for 14 days: 30 minutes |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hand Sweat Severity Score | The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)]. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Group 2 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| OG003 | Group 2 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| OG004 | Group 3 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes |
| OG005 | Group 3 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes |
| OG006 | Group 4 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes |
| OG007 | Group 4 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes |
|
|
|
| Secondary | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 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 (better), 2, 3, 4 (worse) | Intent to Treat Population | Posted | Count of Participants | Participants | Baseline, Week 2 |
|
|
|
|
| Secondary | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2 | Intent to Treat Population | Posted | Mean | Standard Deviation | mg | Baseline, Week 2 |
|
|
|
|
| Secondary | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production | Intent to Treat Population | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 2 |
|
|
|
|
| Secondary | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group | Intent to Treat Population | Posted | Count of Participants | Participants | Baseline, Week 2 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Group 1 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Group 2 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) | 0 | 12 | 0 | 12 | 5 | 12 |
| EG003 | Group 2 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | Group 3 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes | 0 | 12 | 0 | 12 | 1 | 12 |
| EG005 | Group 3 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | Group 4 Active | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes | 0 | 13 | 0 | 13 | 2 | 13 |
| EG007 | Group 4 Vehicle | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes | 0 | 7 | 0 | 7 | 0 | 7 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Compensatory sweating | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
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| Superiority |
| Fisher Exact | 0.154 | Superiority |
| Fisher Exact | 0.646 | Superiority |
| Mean Difference (Final Values) |
| 144.1 |
| 2-Sided |
| 95 |
| -78.6 |
| 366.7 |
| Superiority |
| t-test, 2 sided | 0.058 | Mean Difference (Final Values) | -151.7 | 2-Sided | 95 | -309.0 | 5.7 | Superiority |
| t-test, 2 sided | 0.186 | Mean Difference (Final Values) | 160.6 | 2-Sided | 95 | -611.2 | 290.1 | Superiority |
| Mean Difference (Final Values) |
| 24.26 |
| 2-Sided |
| 95 |
| -54.62 |
| 103.13 |
| Superiority |
| t-test, 2 sided | 0.061 | Mean Difference (Final Values) | -38.14 | 2-Sided | 95 | -78.32 | 2.03 | Superiority |
| t-test, 2 sided | 0.366 | Mean Difference (Final Values) | -39.34 | 2-Sided | 95 | -128.40 | 49.72 | Superiority |
| Superiority |
| Fisher Exact | 0.245 | Superiority |
| Fisher Exact | 0.290 | Superiority |