A Phase 3 interventional study of glycopyrronium Topical Wipes and Vehicle in Hyperhidrosis, sponsored by Journey Medical Corporation. Completed at 20 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Journey Medical Corporation · Phase 3, Interventional, and Treatment
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.
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 353 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Journey Medical Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
glycopyrronium Topical Wipes
Drug: glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Other: Vehicle
Topical wipes containing glycopyrronium
Also known as: DRM04
Vehicle (placebo) topical wipes
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (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
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 - Week 4
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time frame: From Baseline to Week 4
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.
Time frame: From Baseline to Week 4
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
| Milestone | Glycopyrronium | Vehicle |
|---|---|---|
| Started | 234 | 119 |
| Completed | 218 | 113 |
| Not completed | 16 | 6 |
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)
| percent of subjects | Glycopyrronium | Vehicle |
|---|---|---|
| Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4 | 66.1 | 26.9 |
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.
| mg/5 min | Glycopyrronium | Vehicle |
|---|---|---|
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -115.43 ± 66.511 | -81.20 ± 66.714 |
| mg/5 min | Glycopyrronium | Vehicle |
|---|---|---|
| Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -78.77 (-143.97 to -45.48) | -57.94 (-121.85 to -21.16) |
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.
| percent of subjects | Glycopyrronium | Vehicle |
|---|---|---|
| Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 | 61.6 | 27.8 |
| percent of subjects | Glycopyrronium | Vehicle |
|---|---|---|
| Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 | 77.3 | 53.3 |
Collected over Up to 35 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glycopyrronium | 0/232 (0%) | 1/232 (0.4%) | 101/232 (43.5%) |
| Vehicle | 0/118 (0%) | 0/118 (0%) | 22/118 (18.6%) |
| Event | Glycopyrronium | Vehicle |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 1/232 | 0/118 |
| Event | Glycopyrronium | Vehicle |
|---|---|---|
| Dry MouthGastrointestinal disorders | 68/232 | 9/118 |
| Application site painGeneral disorders | 20/232 | 11/118 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 17/232 | 1/118 |
| MydriasisEye disorders | 16/232 | 0/118 |
| HeadacheNervous system disorders | 13/232 | 2/118 |
| Age, Categorical(Participants) | Glycopyrronium | Vehicle | Total |
|---|---|---|---|
| <=18 years | 24 | 15 | 39 |
| Between 18 and 65 years | 210 | 104 | 314 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Glycopyrronium | Vehicle | Total |
|---|---|---|---|
| Female | 121 | 60 | 181 |
| Male | 113 | 59 | 172 |
| Ethnicity (NIH/OMB)(Participants) | Glycopyrronium | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 28 | 15 | 43 |
| Not Hispanic or Latino | 206 | 104 | 310 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Glycopyrronium | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 14 | 42 |
| White | 192 | 102 | 294 |
| More than one race | 11 | 3 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: Undecided
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Journey Medical Corporation