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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020546
Receipt No. R000023721
Scientific Title A skin irritation study of BBI-4000 in healthy adult males (phase 1)
Date of disclosure of the study information 2016/01/18
Last modified on 2016/02/09

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Basic information
Public title A skin irritation study of BBI-4000 in healthy adult males (phase 1)
Acronym A skin irritation study of BBI-4000 (phase 1)
Scientific Title A skin irritation study of BBI-4000 in healthy adult males (phase 1)
Scientific Title:Acronym A skin irritation study of BBI-4000 (phase 1)
Region
Japan

Condition
Condition hyperhidrosis
Classification by specialty
Neurology Dermatology Psychiatry
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate skin irritability and the safety of a single application of BBI-4000 by patch test in healthy adult males
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin irritability at 48 hours and 72 hours after administraion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 7
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BBI-4000 low concentration will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_2 BBI-4000 middle concentration will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_3 BBI-4000 high concentration will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_4 Placebo will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_5 Sodium lauryl sulfate solution (positive-controlled) will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_6 Deionized water (negative-controlled) will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
Interventions/Control_7 Patch test unit only will be applied on the back (paraspinal site) of the study subjects for 48 hours.
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria 1. Healthy volunteers
2. Japanese
3. Does NOT have dermatological diseases such as dermatitis and eczema
4. Does NOT have history of skin rash from e.g. plaster or contact dermatitis metal, cosmetics or household appliance
5. BMI of 18.5 to 25.0 (rounded to one decimal place)
Key exclusion criteria 1. Has a history of glaucoma or enlarged prostate
2. Has a wound, scar, birthmark, or tattoo on the back (paraspinal sites)
3. Complicated with liver, kidney, or heart diseases or hematological disorders or history thereof
4. Has a history of allergic reactions to medications or specific constitutions (e.g. alcohol hypersensitivity)
5. Regularly uses drugs
6. Has a history of drug abuse (narcotics/stimulants/psychotropics) or alcohol dependence
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Watanuki
Organization Kaken Pharmaceutical Co., LTD
Division name Clinical Development Department
Zip code
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL 03-5977-5111
Email watanuki_mitsuru@kaken.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Akamatsu
Organization Kaken Pharmaceutical Co., LTD
Division name Clinical Development Department
Zip code
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL 03-5977-5111
Homepage URL
Email akamatsu_motoki@kaken.co.jp

Sponsor
Institute Kaken Pharmaceutical Co., LTD
Institute
Department

Funding Source
Organization Kaken Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 19 Day
Last follow-up date
2016 Year 02 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2016 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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