Axillary hyperhidrosis in Children (AICHI) study

JRCT ID: jRCT1041230174

Registered date:20/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary axillary hyperhidrosis
• Date of first enrollment: 20/03/2024
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 14age old
• Gender: Both
• Include criteria: Pediatric patients with severe axillary hyperhidrosis who scheduled to prescribe sofpironium, who understand the purpose of the study and give their consent.

Exclude 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)

Related Information

• Primary Sponsor: Oshima Yuichiro