Phase 3
Completed N=564
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Hyperhidrosis
Source: ClinicalTrials.gov NCT02553798 ↗
Enrolled (actual)
564
Serious AEs
1.3%
Results posted
Sep 2018
Primary outcomePrimary: Long-term Safety Assessed Through Adverse Events and Local Skin Reactions — 148; 153; 28; 120 Adverse Events and Local Skin Reactions
◆ Published Evidence
Established
32citations · ~5 / year
A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.
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.
Linked Publications
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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Safety Assessed Through Adverse Events and Local Skin Reactions |
148; 153; 28; 120; 44; 15 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02553798) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.