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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028790
Receipt No. 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

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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
Email 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
Email akemi@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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