NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedPrimary hyperhidrosis
Date of first enrollment16/5/2018
Target sample size270
Countries of recruitmentJapan
Study typeINTERVENTIONAL
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 Outcomesafety, efficacy gravimetric sweat production HDSS
Secondary Outcomesafety, efficacy gravimetric sweat production HDSS HDSM-Ax DLQI

Key inclusion & exclusion criteria

Age minimum12
Age maximum
GenderBOTH
Include criteriaDiagnosed as hyperhidrosis
Exclude criteriaSecondary hyperhidrosis Experienced the first onset or worsening of hyperhidrosis associated with menopause

Related Information

Contact

public contact
Name KAKEN PHARMACEUTICAL CO., LTD. Clinical development department
Address
Telephone
E-mail akamatsu_motoki@kaken.co.jp
Affiliation
scientific contact
Name KAKEN PHARMACEUTICAL CO., LTD. Clinical development department
Address
Telephone
E-mail akamatsu_motoki@kaken.co.jp
Affiliation