JAPIC ID: JapicCTI-183948
Registered date:07/05/2018
A confirmatory study of BBI-4000 gel
Basic Information
| Recruitment status | complete |
|---|---|
| Health condition(s) or Problem(s) studied | Primary hyperhidrosis |
| Date of first enrollment | 16/5/2018 |
| Target sample size | 270 |
| Countries of recruitment | Japan |
| Study type | INTERVENTIONAL |
| Intervention(s) | Intervention name : sofpironium bromide INN of the intervention : sofpironium bromide Dosage And administration of the intervention : once daily Control intervention name : BBI-4000 0% INN of the control intervention : BBI-4000 0% Dosage And administration of the control intervention : once daily |
Outcome(s)
| Primary Outcome | safety, efficacy gravimetric sweat production HDSS |
|---|---|
| Secondary Outcome | safety, efficacy gravimetric sweat production HDSS HDSM-Ax DLQI |
Key inclusion & exclusion criteria
| Age minimum | 12 |
|---|---|
| Age maximum | |
| Gender | BOTH |
| Include criteria | Diagnosed as hyperhidrosis |
| Exclude criteria | Secondary hyperhidrosis Experienced the first onset or worsening of hyperhidrosis associated with menopause |
Related Information
| Primary Sponsor | KAKEN PHARMACEUTICAL CO., LTD. |
|---|---|
| Secondary Sponsor | - |
| Source(s) of Monetary Support | KAKEN PHARMACEUTICAL CO., LTD. |
Contact
| public contact | |
| Name | KAKEN PHARMACEUTICAL CO., LTD. Clinical development department |
| Address | |
| Telephone | |
| akamatsu_motoki@kaken.co.jp | |
| Affiliation | |
| scientific contact | |
| Name | KAKEN PHARMACEUTICAL CO., LTD. Clinical development department |
| Address | |
| Telephone | |
| akamatsu_motoki@kaken.co.jp | |
| Affiliation | |