JAPIC ID: JapicCTI-183948
Registered date:07/05/2018
A confirmatory study of BBI-4000 gel
Basic Information
Recruitment status | complete |
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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 |
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Secondary Outcome | safety, efficacy gravimetric sweat production HDSS HDSM-Ax DLQI |
Key inclusion & exclusion criteria
Age minimum | 12 |
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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. |
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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 |