UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028790 |
|---|---|
| Receipt number | R000032951 |
| Scientific Title | Verification of the effect of a novel barrier improving agent |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2018/02/21 19:34:02 |
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Basic information
Public title
Verification of the effect of a novel barrier improving agent
Acronym
Efficacy test of barrier improving agent
Scientific Title
Verification of the effect of a novel barrier improving agent
Scientific Title:Acronym
Efficacy test of barrier improving agent
Region
| Japan |
Condition
Condition
Congenital keratosis abnormality
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of effectiveness and safety on skin condition by barrier improver for congenital keratosis abnormal skin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement degree of the appearance score using Observer dryness scale before the start of the study and 1 week after application of the barrier improvement agent
Key secondary outcomes
Improvement degree of VAS value of itch
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
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Apply the barrier improving agent to one side(forearm or lower thigh) and placebo to the other side(forearm or lower thigh) twice a day for 1 week
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
Congenital keratosis abnormality
Key exclusion criteria
1.Those who have allergy to the ingredients to be tested
2.For pregnant and lactating women
3.Those who judge that they are inappropriate by the doctor in charge of conducting the study and the supervisor physician
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akemi Yamamoto |
Organization
Asahikawa Medical University
Division name
Dermatological Department
Zip code
Address
Midorigaoka Higashi 2-1-1-1
TEL
+81-166-68-2523
akemi@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akemi Yamamoto |
Organization
Asahikawa Medical University
Division name
Dermatological Department
Zip code
Address
Midorigaoka Higashi 2-1-1-1
TEL
+81-166-68-2523
Homepage URL
akemi@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
旭川医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 24 | 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
| 2017 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032951
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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