JAPIC ID: JapicCTI-183948
Registered date:07/05/2018
A confirmatory study of BBI-4000 gel
Basic Information
| Public title | A confirmatory study of BBI-4000 gel |
|---|---|
| Scientific title | A confirmatory study of BBI-4000 gel in patients with primary axillary hyperhidrosis |
| Recruitment status | complete |
| Health condition(s) or Problem(s) studied | Primary hyperhidrosis |
| Study type | INTERVENTIONAL |
| 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 Size | 270 |
| Date of first enrollment | 16/5/2018 |
| Completion date | 15/01/2019 |
| Countries of recruitment | Japan |
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 | - |
| Source(s) | KAKEN PHARMACEUTICAL CO., LTD. |
Secondary Identifiers
| Secondary ID |
|---|
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 | |
Ethics Reviews
| Status | Approved |
|---|---|
| Approval Date | 26/04/2018 |
| Contact Name | ATAGO Dermatology IRB |
| Contact Address | 1-1-35, 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 IPD | No |
|---|---|
| Plan description | |