UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A using test for four continuous weeks of SC1722 against babies
Title of the study (Brief title)	A using test for four continuous weeks of SC1722 against babies
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety of SC1722 on four continuous weeks using in babies at home.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Doctor's findings such as dryness or scales, erythema, papules, scratch marks on the whole body prior to starting test and at four weeks after test start.
Key secondary outcomes	*Doctor's findings such as dryness or scales, erythema, papules, scratch marks on the whole body prior to starting test and at two weeks after test start. *Measuring stratum corneum water content of skin, transepidermal water transpiration amount of skin prior to starting test and at two and four weeks after test start.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Inspection before test start - Use the test sample on the whole body for two weeks - Inspection such as observation and measurement at two weeks after test start - Use the test sample on the whole body for two weeks - Inspection such as observation and measurement at four weeks after test start
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	28 days-old <=
Age-upper limit	365 days-old >
Gender	Male and Female
Key inclusion criteria	Those who satisfy all of the following conditions 1)Healthy babies (male and female) aged 28 days-old to 11 months-old. 2)Subjects who have their protector (parents or guardians) that are able to show their willingness of participating to the test, and that are able to obtain written consent to participate in the test after understanding explanation of test. 3)Subjects and their protectors(parents or guardians) who are able to come to the institution for all inspections.
Key exclusion criteria	1)Premature babies. 2)Subjects with birth weight >2,500g. 3)Subjects who have severe eczema infantile. 4)Subjects who have skin symptom such as atopic dermatitis. 5)Subjects who have trauma on the part that uses the test sample. 6)Subjects who have possibility to take a lot of sunlight. 7)Subjects who are participating in clinical tests and use tests that apply cosmetic, quasi-drugs and others. 8)Subjects who have allergic symptoms against external medicine, cosmetic, quasi-drugs and others in the past. 9)Subjects who have previous and/or current medical history of serious disease in liver, kidney, myocardial infarction. 10)Subject who are going to hospital and being accepted medical treatment due to disease. 11)Subjects who have their family that are working for cosmetic companies and pharmaceutical companies. 12)Others who have been determined ineligible by investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	Tomohiko Yamaguchi
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name	R&D Department
Address	3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN
TEL	03-5255-6336
Email	yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

Public contact
Name of contact person	Kanako Sakurai
Organization	Inforward, inc
Division name	EBISU skin research center
Address	1-11-2 Ebisu Shibuya-ku, Tokyo 150-0013, JAPAN
TEL	03-5793-8712
Homepage URL
Email	sakurai@inforward.co.jp

Sponsor
Institute	Inforward, inc EBISU skin research center
Institute
Department

Funding Source
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD. R&D Department
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medimate Co., Ltd.
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	株式会社インフォワード Inforward, inc

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 05 Month 10 Day
Last follow-up date	2018 Year 08 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036871