Unique ID issued by UMIN | UMIN000020546 |
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Receipt number | 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 12:56:25 |
A skin irritation study of BBI-4000 in healthy adult males (phase 1)
A skin irritation study of BBI-4000 (phase 1)
A skin irritation study of BBI-4000 in healthy adult males (phase 1)
A skin irritation study of BBI-4000 (phase 1)
Japan |
hyperhidrosis
Neurology | Dermatology | Psychiatry |
Plastic surgery |
Others
NO
To investigate skin irritability and the safety of a single application of BBI-4000 by patch test in healthy adult males
Safety
Skin irritability at 48 hours and 72 hours after administraion
Interventional
Parallel
Non-randomized
Double blind -all involved are blinded
Placebo
7
Treatment
Medicine |
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.
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.
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.
Placebo will be applied on the back (paraspinal site) of the study subjects for 48 hours by using a closed-type patch test unit.
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.
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.
Patch test unit only will be applied on the back (paraspinal site) of the study subjects for 48 hours.
20 | years-old | <= |
65 | years-old | > |
Male
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)
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
28
1st name | |
Middle name | |
Last name | Mitsuru Watanuki |
Kaken Pharmaceutical Co., LTD
Clinical Development Department
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
03-5977-5111
watanuki_mitsuru@kaken.co.jp
1st name | |
Middle name | |
Last name | Motoki Akamatsu |
Kaken Pharmaceutical Co., LTD
Clinical Development Department
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
03-5977-5111
akamatsu_motoki@kaken.co.jp
Kaken Pharmaceutical Co., LTD
Kaken Pharmaceutical Co., LTD
Profit organization
NO
2016 | Year | 01 | Month | 18 | Day |
Unpublished
Completed
2015 | Year | 11 | Month | 30 | Day |
2016 | Year | 01 | Month | 19 | Day |
2016 | Year | 02 | Month | 05 | Day |
2016 | Year | 01 | Month | 13 | Day |
2016 | Year | 02 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023721
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