Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Summary
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.
Timeline
- Start
- 2015-08
- Primary completion
- 2016-04
- Completion
- 2016-04
Outcome
Met primary endpoint
registry NUMBER Glycopyrronium: 66.1 percent of subjects NUMBER Vehicle: 26.9 percent of subjects analysis (other test); Glycopyrronium vs Vehicle; p < 0.001; Cochran-Mantel-Haenszel NCT02530294 ↗
registry LEAST_SQUARES_MEAN Glycopyrronium: -115.43 (Standard Deviation 66.511) mg/5 min LEAST_SQUARES_MEAN Vehicle: -81.20 (Standard Deviation 66.714) mg/5 min analysis (other test); Glycopyrronium vs Vehicle; p <0.001; ANCOVA NCT02530294 ↗
registry MEDIAN Glycopyrronium: -78.77 (-143.97 to -45.48) mg/5 min MEDIAN Vehicle: -57.94 (-121.85 to -21.16) mg/5 min analysis (other test); Glycopyrronium vs Vehicle; p < 0.001; ANCOVA NCT02530294 ↗
Publications
- Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.
- Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.
- Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrronium | Unknown | 3.75 % | Topical |