NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000020546

Registered date:18/01/2016

A skin irritation study of BBI-4000 in healthy adult males (phase 1)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedhyperhidrosis
Date of first enrollment2016/01/19
Target sample size28
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeSkin irritability at 48 hours and 72 hours after administraion
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
GenderMale
Include criteria1. 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)
Exclude criteria1. 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

Related Information

Contact

public contact
Name Motoki Akamatsu
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-5977-5111
E-mail akamatsu_motoki@kaken.co.jp
Affiliation Kaken Pharmaceutical Co., LTD Clinical Development Department
scientific contact
Name Mitsuru Watanuki
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-5977-5111
E-mail watanuki_mitsuru@kaken.co.jp
Affiliation Kaken Pharmaceutical Co., LTD Clinical Development Department