A long term safety study of BBI-4000 gel

A long term safety study of BBI-4000 gel in patients with primary axillary hyperhidrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223946

Enrollment

150

Registered

2018-06-15

Start date

2018-06-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hyperhidrosis

Interventions

investigational material(s) Generic name etc : sofpironium bromide INN of investigational material : sofpironium bromide Therapeutic category code : 129 Other agents affecting peripheral nervous syste

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed as hyperhidrosis

Exclusion criteria

Exclusion criteria: Secondary hyperhidrosis Experienced the first onset or worsening of hyperhidrosis associated with menopause

Design outcomes

Primary

Measure	Time frame
safety Adverse events	—

Secondary

Measure	Time frame
efficacy Gravimetric sweat production HDSS HDSM-Ax DLQI	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026