A Phase 3 interventional study of Glycopyrronium Topical Wipes in Hyperhidrosis, sponsored by Journey Medical Corporation. Completed at 48 sites in 2 countries. 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
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.
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 564 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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
Also known as: DRM04
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
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
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
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
| Milestone | Glycopyrronium |
|---|---|
| Started | 564 |
| Completed | 226 |
| Not completed | 338 |
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.
| Adverse Events and Local Skin Reactions | Glycopyrronium |
|---|---|
| Mild AEs | 148 |
| Moderate AEs | 153 |
| Severe AEs | 28 |
| Mild LSRs | 120 |
| Moderate LSRs | 44 |
| Severe LSRs | 15 |
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 |
|---|---|
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | -95.68 ± 140.806 |
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.
| participants | Glycopyrronium |
|---|---|
| 3 - point improvement | 72 |
| 2 - point improvement | 204 |
| 1 - point improvement | 135 |
| no improvement | 26 |
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.
| scores on a scale | Glycopyrronium |
|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET | -8.7 ± 6.24 |
Collected over up to 45 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glycopyrronium | 0/550 (0%) | 7/550 (1.3%) | 178/550 (32.4%) |
| Event | Glycopyrronium |
|---|---|
| DiverticulitisInfections and infestations | 1/550 |
| Infectious colitisInfections and infestations | 1/550 |
| Affective disorderPsychiatric disorders | 1/550 |
| Suicide attemptPsychiatric disorders | 1/550 |
| MydriasisEye disorders | 1/550 |
| Chest painGeneral disorders | 1/550 |
| ConcussionInjury, poisoning and procedural complications | 1/550 |
| Event | Glycopyrronium |
|---|---|
| Dry MouthGastrointestinal disorders | 93/550 |
| Vision blurredEye disorders | 37/550 |
| Application Site PainGeneral disorders | 35/550 |
| NasopharyngitisInfections and infestations | 32/550 |
| MydriasisEye disorders | 28/550 |
| Age, Categorical(Participants) | Glycopyrronium |
|---|---|
| <=18 years | 60 |
| Between 18 and 65 years | 499 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Glycopyrronium |
|---|---|
| Female | 309 |
| Male | 255 |
| Ethnicity (NIH/OMB)(Participants) | Glycopyrronium |
|---|---|
| Hispanic or Latino | 97 |
| Not Hispanic or Latino | 467 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Glycopyrronium |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 64 |
| White | 470 |
| More than one race | 24 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Journey Medical Corporation