UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the effect of a novel barrier improving agent
Title of the study (Brief title)	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	Akemi Yamamoto
Organization	Asahikawa Medical University
Division name	Dermatological Department
Address	Midorigaoka Higashi 2-1-1-1
TEL	+81-166-68-2523
Email	akemi@asahikawa-med.ac.jp

Public contact
Name of contact person	Akemi Yamamoto
Organization	Asahikawa Medical University
Division name	Dermatological Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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