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) studied | hyperhidrosis |
| Date of first enrollment | 2016/01/19 |
| Target sample size | 28 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | Skin irritability at 48 hours and 72 hours after administraion |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Kaken Pharmaceutical Co., LTD |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kaken Pharmaceutical Co., LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Motoki Akamatsu |
| Address | 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-5977-5111 |
| 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 |
| watanuki_mitsuru@kaken.co.jp | |
| Affiliation | Kaken Pharmaceutical Co., LTD Clinical Development Department |