UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021791 |
|---|---|
| Receipt number | R000025132 |
| Scientific Title | Patch test of skin external preparations. |
| Date of disclosure of the study information | 2016/04/07 |
| Last modified on | 2016/04/20 15:41:15 |
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Basic information
Public title
Patch test of skin external preparations.
Acronym
Patch test of skin external preparations.
Scientific Title
Patch test of skin external preparations.
Scientific Title:Acronym
Patch test of skin external preparations.
Region
| Japan |
Condition
Condition
Healthy adults.
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the primary skin irritation of the skin external preparations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin reactions immediately, 1day, and 7days after 48h skin external preparations patch.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
48h-closed patch of 6 kinds of skin external preparations on the inner upper arm.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Healthy men and women.
Key exclusion criteria
-The person who has medical treatment.
-The person who has any allergies.
-The person who has an experience of allergy by any drugs or cosmetics.
-Pregnant woman or suspicion of pregnancy.
-The person who has extensive eczema or sores in their test area (inner upper arm).
-The person who judged as unfit for this test by P.I. or the parties concerned.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Yano |
Organization
Yaesu Nihonbashi Skin Clinic
Division name
Director
Zip code
Address
1-5-17, Yaesu, Chuo-ku, Tokyo, 103-0028, JAPAN
TEL
03-6202-1200
yanosyo-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Yano |
Organization
Yaesu Nihonbashi Skin Clinic
Division name
Director
Zip code
Address
1-5-17, Yaesu, Chuo-ku, Tokyo, 103-0028, JAPAN
TEL
03-6202-1200
Homepage URL
yanosyo-tky@umin.ac.jp
Sponsor or person
Institute
Yaesu Nihonbashi Skin Clinic
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
やえす日本橋ヒフ科（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 07 | 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
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 04 | Month | 17 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2016 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025132
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
