UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006035
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Acronym A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Scientific Title A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Scientific Title:Acronym A clinical research on the bacterial count measurement for the resident bacterial flora of human skin
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -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.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Bacterial count in the bacterial sample
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The bacillus sample is gathered from the inguinal region on the bacillus sample collection day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (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
Key exclusion 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.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Hasunuma
Organization Bio-Iatoric Center, Research Center for Clinical Pharmacology
Kitasato University
Division name Bio-Iatoric Center
Zip code
Address 5-9-1, Shirokane, Minato-ku, Tokyo
TEL 03-5791-6350
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Hasunuma
Organization Bio-Iatoric Center, Research Center for Clinical Pharmacology
Division name Bio-Iatoric Center
Zip code
Address 5-9-1, Shirokane, Minato-ku, Tokyo
TEL 03-5791-6350
Homepage URL
Email

Sponsor
Institute Bio-Iatoric Center, Research Center for Clinical Pharmacology
Kitasato University
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北里大学臨床薬理研究所 バイオイアトリックセンター

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 25 Day
Last modified on
2011 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.