Palmar Hyperhidrosis
Conditions
Brief summary
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
Detailed description
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
Interventions
DRUGGlycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
DRUGVehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Sponsors
Journey Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent and assent (for subjects under legal adult age). 2. Age ≥9 years. 3. Primary palmar hyperhidrosis for at least 6 months duration. 4. Average sweat severity score of ≥4 at Baseline. 5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline. 6. Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol. 7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
Exclusion criteria
1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%. 2. Prior surgical procedure for hyperhidrosis. 3. Iontophoresis for the palms within 4 weeks of Baseline. 4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline. 5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands. 6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism). 7. Known history of Sjögren's syndrome or Sicca syndrome. 8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis. 9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | Baseline, Week 2 | The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | Baseline, 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) |
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Baseline, 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 |
| Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | Baseline, 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 |
| Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | Baseline, 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) | 12 |
| Group 1 Vehicle Vehicle applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) | 6 |
| Group 2 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) | 12 |
| Group 2 Vehicle Vehicle applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) | 4 |
| Group 3 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes | 12 |
| Group 3 Vehicle Vehicle applied to the hands once daily for 14 days: 15 minutes | 6 |
| Group 4 Active Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes | 13 |
| Group 4 Vehicle Vehicle applied to the hands once daily for 14 days: 30 minutes | 7 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1 Active | Group 1 Vehicle | Group 2 Active | Group 2 Vehicle | Group 3 Active | Group 3 Vehicle | Group 4 Active | Group 4 Vehicle | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 8.95 | 34.5 years STANDARD_DEVIATION 15.93 | 29.2 years STANDARD_DEVIATION 11.57 | 47.5 years STANDARD_DEVIATION 17.56 | 28.2 years STANDARD_DEVIATION 12.45 | 32.5 years STANDARD_DEVIATION 7.97 | 26.6 years STANDARD_DEVIATION 9.54 | 37.1 years STANDARD_DEVIATION 13.91 | 31.1 years STANDARD_DEVIATION 12.27 |
| Hand Sweat Severity Score | 6.78 units on a scale STANDARD_DEVIATION 1.646 | 7.40 units on a scale STANDARD_DEVIATION 0.718 | 7.56 units on a scale STANDARD_DEVIATION 1.45 | 8.10 units on a scale STANDARD_DEVIATION 1.92 | 6.93 units on a scale STANDARD_DEVIATION 1.689 | 7.37 units on a scale STANDARD_DEVIATION 2.017 | 7.58 units on a scale STANDARD_DEVIATION 1.399 | 8.01 units on a scale STANDARD_DEVIATION 1.078 | 7.37 units on a scale STANDARD_DEVIATION 1.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 7 Participants | 4 Participants | 9 Participants | 4 Participants | 12 Participants | 5 Participants | 53 Participants |
| Region of Enrollment United States | 12 participants | 6 participants | 12 participants | 4 participants | 12 participants | 6 participants | 13 participants | 7 participants | 72 participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 7 Participants | 4 Participants | 8 Participants | 3 Participants | 8 Participants | 5 Participants | 47 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 5 Participants | 0 Participants | 4 Participants | 3 Participants | 5 Participants | 2 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 | 0 / 12 | 0 / 4 | 0 / 12 | 0 / 6 | 0 / 13 | 0 / 7 |
| other Total, other adverse events | 5 / 12 | 2 / 6 | 5 / 12 | 1 / 4 | 1 / 12 | 2 / 6 | 2 / 13 | 0 / 7 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 12 | 0 / 4 | 0 / 12 | 0 / 6 | 0 / 13 | 0 / 7 |
Outcome results
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 \[score on a scale from 0 (better) -10 (worse)\].
Time frame: Baseline, Week 2
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Active | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -2.14 score on a scale | Standard Deviation 2.199 |
| Group 1 Vehicle | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -0.56 score on a scale | Standard Deviation 0.73 |
| Group 2 Active | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -1.64 score on a scale | Standard Deviation 1.41 |
| Group 2 Vehicle | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -3.03 score on a scale | Standard Deviation 2.161 |
| Group 3 Active | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -2.53 score on a scale | Standard Deviation 2.223 |
| Group 3 Vehicle | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -2.20 score on a scale | Standard Deviation 1.084 |
| Group 4 Active | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -1.30 score on a scale | Standard Deviation 2.062 |
| Group 4 Vehicle | Mean Change From Baseline to Week 2 in Hand Sweating Severity Score | -1.34 score on a scale | Standard Deviation 1.909 |
p-value: 0.24495% CI: [-3.76, 0.6]Wilcoxon (Mann-Whitney)
p-value: 0.16895% CI: [-0.65, 3.43]Wilcoxon (Mann-Whitney)
p-value: 0.69995% CI: [-2.39, 1.72]Wilcoxon (Mann-Whitney)
p-value: 0.83395% CI: [-1.94, 2.02]Wilcoxon (Mann-Whitney)
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
Time frame: Baseline, Week 2
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Active | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -69.8 mg | Standard Deviation 162.54 |
| Group 1 Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 136.7 mg | Standard Deviation 320.57 |
| Group 2 Active | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -15.3 mg | Standard Deviation 53.14 |
| Group 2 Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -159.4 mg | Standard Deviation 354.38 |
| Group 3 Active | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -113.5 mg | Standard Deviation 164.1 |
| Group 3 Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 38.1 mg | Standard Deviation 106.3 |
| Group 4 Active | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -58.6 mg | Standard Deviation 139.7 |
| Group 4 Vehicle | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 102.0 mg | Standard Deviation 767.52 |
p-value: 0.09395% CI: [-451.9, 38.9]t-test, 2 sided
p-value: 0.18695% CI: [-78.6, 366.7]t-test, 2 sided
p-value: 0.05895% CI: [-309, 5.7]t-test, 2 sided
p-value: 0.18695% CI: [-611.2, 290.1]t-test, 2 sided
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
Time frame: Baseline, Week 2
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Active | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -17.1 Percent change | Standard Deviation 28.26 |
| Group 1 Vehicle | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 16.5 Percent change | Standard Deviation 60.4 |
| Group 2 Active | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -7.5 Percent change | Standard Deviation 65.53 |
| Group 2 Vehicle | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -31.8 Percent change | Standard Deviation 51.29 |
| Group 3 Active | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -26.8 Percent change | Standard Deviation 39.17 |
| Group 3 Vehicle | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 11.4 Percent change | Standard Deviation 34.96 |
| Group 4 Active | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | -17.7 Percent change | Standard Deviation 40.43 |
| Group 4 Vehicle | Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 | 21.7 Percent change | Standard Deviation 145.81 |
p-value: 0.06195% CI: [-78.32, 2.03]t-test, 2 sided
p-value: 0.1395% CI: [-78.42, 11.17]t-test, 2 sided
p-value: 0.51895% CI: [-54.62, 103.13]t-test, 2 sided
p-value: 0.36695% CI: [-128.4, 49.72]t-test, 2 sided
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)
Time frame: Baseline, Week 2
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Active | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 3 Participants |
| Group 1 Vehicle | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 0 Participants |
| Group 2 Active | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 1 Participants |
| Group 2 Vehicle | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 2 Participants |
| Group 3 Active | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 1 Participants |
| Group 3 Vehicle | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 2 Participants |
| Group 4 Active | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 3 Participants |
| Group 4 Vehicle | Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 | 2 Participants |
p-value: 1Fisher Exact
p-value: 0.589Fisher Exact
p-value: 0.154Fisher Exact
p-value: 0.646Fisher Exact
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
Time frame: Baseline, Week 2
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Active | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 1 Participants |
| Group 1 Vehicle | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 1 Participants |
| Group 2 Active | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 3 Participants |
| Group 2 Vehicle | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 2 Participants |
| Group 3 Active | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 4 Participants |
| Group 3 Vehicle | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 0 Participants |
| Group 4 Active | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 2 Participants |
| Group 4 Vehicle | Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 | 3 Participants |
p-value: 0.515Fisher Exact
p-value: 0.56Fisher Exact
p-value: 0.245Fisher Exact
p-value: 0.29Fisher Exact