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

Public titleA confirmatory study of BBI-4000 gel
Scientific titleA confirmatory study of BBI-4000 gel in patients with primary axillary hyperhidrosis
Recruitment statuscomplete
Health condition(s) or Problem(s) studiedPrimary hyperhidrosis
Study typeINTERVENTIONAL
Phase
Study design
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
Sample Size270
Date of first enrollment16/5/2018
Completion date15/01/2019
Countries of recruitmentJapan

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

Primary SponsorKAKEN PHARMACEUTICAL CO., LTD.
Secondary-
Source(s)KAKEN PHARMACEUTICAL CO., LTD.

Secondary Identifiers

Secondary ID

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

Ethics Reviews

StatusApproved
Approval Date26/04/2018
Contact NameATAGO Dermatology IRB
Contact Address1-1-35, Shibadaimon, Minato-ku, Tokyo, Japan
Contact Phone
Contact Email

Summary Results

Date of posting of results summaries
Date of the first journal publication of results
URL hyperlink(s) related to results and publications
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Brief Summary
URL link to protocol file(s) with version and date

IPD sharing statement

Plan to share IPDNo
Plan description