Trial · NCT02553798
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
NCT02553798, Phase 3, Completed, Journey Medical Corporation; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis. Trials, record NCT02553798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02553798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
- NCT number
- NCT02553798
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 564 participants, actual
- Lead sponsor
- Journey Medical Corporation
- Conditions
- Hyperhidrosis
- Interventions
- Glycopyrronium Topical Wipes
- First posted
- 2015-09-18
- Last updated
- 2021-08-25
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Other | 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. |
| Other | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 44 | Participant | Adverse Events and Local Skin Reactions | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | Participant | mg/5 min | MEAN |
| OTHER_PRE_SPECIFIED | Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET | Participant | participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | Participant | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Mild AEs | 148 | Adverse Events and Local Skin Reactions | |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Moderate AEs | 153 | Adverse Events and Local Skin Reactions | |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Severe AEs | 28 | Adverse Events and Local Skin Reactions | |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Mild LSRs | 120 | Adverse Events and Local Skin Reactions | |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Moderate LSRs | 44 | Adverse Events and Local Skin Reactions | |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | Glycopyrronium | Severe LSRs | 15 | Adverse Events and Local Skin Reactions | |
| Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 | Glycopyrronium | -95.68 | Standard Deviation 140.806 | mg/5 min | |
| Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | Glycopyrronium | 3 - point improvement | 72 | participants | |
| Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | Glycopyrronium | 2 - point improvement | 204 | participants | |
| Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) | Glycopyrronium | 1 - point improvement | 135 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glycopyrronium | 564 | |
| Overall Study | COMPLETED | Glycopyrronium | 226 | |
| Overall Study | NOT COMPLETED | Glycopyrronium | 338 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry Mouth | Gastrointestinal disorders | Glycopyrronium | 93 | 550 | |
| other | Nasopharyngitis | Infections and infestations | Glycopyrronium | 32 | 550 | |
| other | Application Site Pain | General disorders | Glycopyrronium | 35 | 550 | |
| other | Vision blurred | Eye disorders | Glycopyrronium | 37 | 550 | |
| other | Mydriasis | Eye disorders | Glycopyrronium | 28 | 550 | |
| serious | Diverticulitis | Infections and infestations | Glycopyrronium | 1 | 550 | |
| serious | Infectious colitis | Infections and infestations | Glycopyrronium | 1 | 550 | |
| serious | Affective disorder | Psychiatric disorders | Glycopyrronium | 1 | 550 | |
| serious | Suicide attempt | Psychiatric disorders | Glycopyrronium | 1 | 550 | |
| serious | Mydriasis | Eye disorders | Glycopyrronium | 1 | 550 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glycopyrronium | 0 | 550 |
| Total, other adverse events | Glycopyrronium | 178 | 550 |
| Total, serious adverse events | Glycopyrronium | 7 | 550 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31111409 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02553798
GET https://conductscience.org/api/trials/v1/NCT02553798/registered