UMIN ID: UMIN000006035
Registered date:25/07/2011
A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Healthy adults |
Date of first enrollment | 2011/07/01 |
Target sample size | 5 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | The bacillus sample is gathered from the inguinal region on the bacillus sample collection day. |
Outcome(s)
Primary Outcome | Bacterial count in the bacterial sample |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1)With a medical history of skin allergies such as contact dermatitis and atopic dermatitis (2)Received the investigational drug, unapproved drugs, or any treatment using unapproved medical device within 16 weeks prior to informed consent (3)Bathed in swimming pool or public bath within 2 weeks prior to informed consent (4)Bathed in hot tub or took a shower on the day before the bacterial sample collection (5)Received antibacterial drugs, antibiotics, steroids, or other medicine including OTC drugs that might affect the resident bacterial flora of normal skin within 1 week prior to the bacterial sample collection day. (6)Being pregnant, lactating, or at a risk of pregnancy (7)Not willing to contraception (8)Deemed ineligible for participation in the study in the investigator's or the co-investigator's opinion In the criteria of (2), (3) and (5)the day of informed consent or the day of bacterial sample collection is not included in the specified period. |
Related Information
Primary Sponsor | Bio-Iatoric Center, Research Center for Clinical Pharmacology Kitasato University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Otsuka Pharmaceutical Factory, Inc. |
Secondary ID(s) |
Contact
public contact | |
Name | Tomoko Hasunuma |
Address | 5-9-1, Shirokane, Minato-ku, Tokyo Japan |
Telephone | 03-5791-6350 |
Affiliation | Bio-Iatoric Center, Research Center for Clinical Pharmacology Bio-Iatoric Center |
scientific contact | |
Name | Tomoko Hasunuma |
Address | 5-9-1, Shirokane, Minato-ku, Tokyo Japan |
Telephone | 03-5791-6350 |
Affiliation | Bio-Iatoric Center, Research Center for Clinical Pharmacology Kitasato University Bio-Iatoric Center |