Unique ID issued by UMIN | UMIN000006035 |
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Receipt number | R000007144 |
Scientific Title | A clinical research on the bacterial count measurement for the resident bacterial flora of human skin |
Date of disclosure of the study information | 2011/07/25 |
Last modified on | 2011/09/30 22:23:44 |
A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Japan |
Healthy adults
Adult |
Others
NO
To confirm whether the resident bacterial count of the normal skin sample can be measured by a combination method of the agar plate method using a bacterial spreader and that using a spiral plater.
Others
To confirm whether the resident bacterial count of the normal skin sample can be measured by a combination method of the agar plate method using a bacterial spreader and that using a spiral plater.
Not applicable
Bacterial count in the bacterial sample
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Maneuver |
The bacillus sample is gathered from the inguinal region on the bacillus sample collection day.
20 | years-old | <= |
Not applicable |
Male and Female
(1)Not younger than 20 on the day of informed consent
(2)Be able to provide written informed consent
(3)With healthy dermatological condition, as follows, at the test site
-No dermatopathy, such as eczema, dermatitis, or abnormal pigmentation
-No wounds or scars
-No inflammation due to sunburn
-No history of hypersensitivity to drugs
-No abnormalities at the test site
(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.
5
1st name | |
Middle name | |
Last name | Tomoko Hasunuma |
Bio-Iatoric Center, Research Center for Clinical Pharmacology
Kitasato University
Bio-Iatoric Center
5-9-1, Shirokane, Minato-ku, Tokyo
03-5791-6350
1st name | |
Middle name | |
Last name | Tomoko Hasunuma |
Bio-Iatoric Center, Research Center for Clinical Pharmacology
Bio-Iatoric Center
5-9-1, Shirokane, Minato-ku, Tokyo
03-5791-6350
Bio-Iatoric Center, Research Center for Clinical Pharmacology
Kitasato University
Otsuka Pharmaceutical Factory, Inc.
Profit organization
Japan
NO
北里大学臨床薬理研究所 バイオイアトリックセンター
2011 | Year | 07 | Month | 25 | Day |
Unpublished
Completed
2011 | Year | 06 | Month | 23 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 07 | Month | 25 | Day |
2011 | Year | 09 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007144
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