A pharmacokinetic study of BBI-4000 gel in patients with primary focal hyperhidrosis in Japan

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071210041

Enrollment

Registered

2021-07-09

Start date

2021-07-31

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 focal hyperhidrosis

Interventions

apply appropriate amount of BBI-4000 gel 0%, 5% or 15% to the affected areas of the skin once daily or twice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged >=20 and =18.0 and <30.0 at screening 3. Diagnosed as having primary focal hyperhidrosis in the screening interview 4. Hyperhidrosis disease severity scale (HDSS) of 3 or 4 at screening

Exclusion criteria

Exclusion criteria: 1. Secondary hyperhidrosis 2. Whose hyperhidrosis symptoms started or worsened due to menopause 3. Indicated forthoracic sympathectomy 4. Identified with findings other than hyperhidrosis at or near the site of study drug administration on the day of admission at baseline 5. Diagnosed by the investigator /sub-investigator with a complication that can disrupt normal sweat production 6. Diagnosed by the investigator /sub-investigator with glaucoma, prostatic hypertrophy, or any other complications that can be exacerbated by using of anticholinergics. 7. Complicated with hyperallergic to anticholinergics or topical agents, or history thereof

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of BBI-4000 and PK parameters	—

Contacts

Public ContactToshiyuki Yorozuya

Kaken Pharmaceutical Co. Ltd.

bbi-4000-09@kaken.co.jp+81-70-8698-2284

Outcome results

None listed

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