A skin irritation study of BBI-4000 in healthy adult males (phase 1)

A skin irritation study of BBI-4000 in healthy adult males (phase 1) - A skin irritation study of BBI-4000 (phase 1)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020546

Enrollment

Registered

2016-01-18

Start date

2016-01-19

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

hyperhidrosis

Interventions

BBI-4000 low concentration will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit. BBI-4000 middle concentration will be applied on the

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers 2. Japanese 3. Does NOT have dermatological diseases such as dermatitis and eczema 4. Does NOT have history of skin rash from e.g. plaster or contact dermatitis metal, cosmetics or household appliance 5. BMI of 18.5 to 25.0 (rounded to one decimal place)

Exclusion criteria

Exclusion criteria: 1. Has a history of glaucoma or enlarged prostate 2. Has a wound, scar, birthmark, or tattoo on the back (paraspinal sites) 3. Complicated with liver, kidney, or heart diseases or hematological disorders or history thereof 4. Has a history of allergic reactions to medications or specific constitutions (e.g. alcohol hypersensitivity) 5. Regularly uses drugs 6. Has a history of drug abuse (narcotics/stimulants/psychotropics) or alcohol dependence

Design outcomes

Primary

Measure	Time frame
Skin irritability at 48 hours and 72 hours after administraion	—

Countries

Japan

Contacts

Public ContactMotoki Akamatsu

Kaken Pharmaceutical Co., LTD Clinical Development Department

akamatsu_motoki@kaken.co.jp03-5977-5111

Outcome results

None listed

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