Primary axillary hyperhidrosis Primary axillary hyperhidrosis
Conditions
Interventions
None listed
Sponsors
Oshima Yuichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pediatric patients with severe axillary hyperhidrosis who scheduled to prescribe sofpironium, who understand the purpose of the study and give their consent.
Exclusion criteria
Exclusion criteria: The relevant therapy included herbal medicines for reducing symptoms of hyperhidrosis. Systemic and topical anticholinergics, oral cholinergic agonists, oral cholinergic agonists, serotonin agonsts, dopamine partial agonists, tricyclic antidepressants, aluminum chloride, medications for hyperhidrosis approved outside Japan, and tap water iontophoresis (within 30 days) Botulinum toxin (within 9 months). In addition, patients with angle-closure glaucoma, patients with dysuria due to benign prostatic hyperplasia, or patients with a history of hypersensitivity to any of the ingredients of sofpironium (active ingredient: sofpironium bromide; additives: hydroxypropyl cellulose, hexylene glycol, isopropyl myristate, anhydrous citric acid, anhydrous ethanol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the effectiveness was change in the proportion of patients with an HDSS score of 1 or 2 during the 2,4-week study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean HDSS score from baseline to Week 2,4. Change in the mean CDLQI score from baseline to Week 4. Change in the mean VAS for Sweating from baseline to Week 2,4 | — |
Contacts
Public ContactYuichiro Oshima
Aichi Medical University School of Medicine
Outcome results
None listed