Hyperhidrosis
Conditions
Brief summary
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Detailed description
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
Interventions
Glycopyrronium Topical Wipes
Sponsors
Journey Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance * Male or females
Exclusion criteria
* Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated * Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy * Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 44 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET | 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. |
| Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET | The Dermatology Life Quality Index 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. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glycopyrronium Glycopyrronium Topical Wipes | 564 |
| Total | 564 |
Baseline characteristics
| Characteristic | Glycopyrronium |
|---|---|
| Age, Categorical <=18 years | 60 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 499 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 467 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants |
| Race (NIH/OMB) More than one race | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 470 Participants |
| Sex: Female, Male Female | 309 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 550 |
| other Total, other adverse events | 178 / 550 |
| serious Total, serious adverse events | 7 / 550 |
Outcome results
Primary
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
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.
Time frame: Day 1 - Week 44
Population: Participant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Mild AEs | 148 Adverse Events and Local Skin Reactions |
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Moderate AEs | 153 Adverse Events and Local Skin Reactions |
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Severe AEs | 28 Adverse Events and Local Skin Reactions |
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Mild LSRs | 120 Adverse Events and Local Skin Reactions |
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Moderate LSRs | 44 Adverse Events and Local Skin Reactions |
| Glycopyrronium | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Severe LSRs | 15 Adverse Events and Local Skin Reactions |
Other Pre-specified
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
The Dermatology Life Quality Index 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.
Time frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Population: Participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET | -8.7 scores on a scale | Standard Deviation 6.24 |
Other Pre-specified
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
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.
Time frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Population: Participant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glycopyrronium | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | 3 - point improvement | 72 participants |
| Glycopyrronium | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | 2 - point improvement | 204 participants |
| Glycopyrronium | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | 1 - point improvement | 135 participants |
| Glycopyrronium | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | no improvement | 26 participants |
Other Pre-specified
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: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Population: Participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glycopyrronium | Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -95.68 mg/5 min | Standard Deviation 140.806 |