Hyperhidrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Topical wipes containing glycopyrronium
OTHERVehicle
Vehicle (placebo) topical wipes
Sponsors
Journey Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 9 years of age. * Primary, axillary hyperhidrosis of at least 6 months duration * Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline * Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline * Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically
Exclusion criteria
* Prior surgical procedure for hyperhidrosis. * Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational). * Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1. * Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials. * Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline. * Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline. * Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months. * Other treatment with glycopyrrolate within 4 weeks prior to Baseline. * Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis. * History of Sjögren's syndrome or Sicca syndrome. * History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness. * Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy. * History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. * Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4 | From Baseline to 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: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered) |
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | 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. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | From Baseline to 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) |
| 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 | — |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glycopyrronium glycopyrronium Topical Wipes | 229 |
| Vehicle glycopyrronium Topical Wipes, Vehicle | 115 |
| Total | 344 |
Baseline characteristics
| Characteristic | Glycopyrronium | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 10 Participants | 34 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 204 Participants | 101 Participants | 305 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 23 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 92 Participants | 275 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 16 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 182 Participants | 94 Participants | 276 Participants |
| Sex: Female, Male Female | 130 Participants | 60 Participants | 190 Participants |
| Sex: Female, Male Male | 99 Participants | 55 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 227 | 0 / 114 |
| other Total, other adverse events | 68 / 227 | 16 / 114 |
| serious Total, serious adverse events | 1 / 227 | 0 / 114 |
Outcome results
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.
Time frame: From Baseline to Week 4
Population: Participant
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -102.00 mg/5 min | Standard Deviation 176.136 |
| Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -100.34 mg/5 min | Standard Deviation 172.276 |
p-value: =0.065ANCOVA
Primary
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Time frame: Baseline - Week 4
Population: Participant
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data | -100.56 mg/5 min | Standard Deviation 98.151 |
| Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data | -88.08 mg/5 min | Standard Deviation 95.695 |
p-value: =0.001ANCOVA
Primary
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time frame: From Baseline to Week 4
Population: Participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Glycopyrronium | Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -80.79 mg/5 min |
| Vehicle | Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -65.81 mg/5 min |
p-value: =0.065ANCOVA
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: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating) 3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount) 4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Time frame: From Baseline to Week 4
Population: Participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glycopyrronium | Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4 | 52.8 percent of subjects |
| Vehicle | Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4 | 28.3 percent of subjects |
p-value: <0.001Cochran-Mantel-Haenszel
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)
Time frame: From Baseline to Week 4
Population: Participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glycopyrronium | Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | 56.5 percent of subjects |
| Vehicle | Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | 23.7 percent of subjects |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time frame: From Baseline to Week 4
Population: Participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glycopyrronium | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | 72.4 percent of subjects |
| Vehicle | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | 53.2 percent of subjects |
p-value: <0.001Cochran-Mantel-Haenszel