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

JRCT ID: jRCT2071210041

Registered date:09/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary focal hyperhidrosis
• Date of first enrollment: 31/07/2021
• Target sample size: 24
• Study type: Interventional
• Intervention(s): apply appropriate amount of BBI-4000 gel 0%, 5% or 15% to the affected areas of the skin once daily or twice daily

Outcome(s)

• Primary Outcome: Plasma concentrations of BBI-4000 and PK parameters

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1. Aged >=20 and <65 years at the time of consent
2. BMI >=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

Exclude 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

Related Information

• Primary Sponsor: Yonemura Takuma