UMIN-CTR Clinical Trial

Basic information
Public title	A using test for four continuous weeks of C-271 in babies
Acronym	A using test for four continuous weeks of C-271 in babies
Scientific Title	A using test for four continuous weeks of C-271 in babies
Scientific Title:Acronym	A using test for four continuous weeks of C-271 in 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 C-271 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	Changes over time of the systemic skin, between screening visit and after four weeks visit, observed by the Investigators, such as dryness or scale, desquamation, erythema, papules, scratch mark, feeling of stimulation and pruritus.
Key secondary outcomes	* Changes over time of the systemic skin, between screening visit and after two weeks visit, observed by the Investigators, such as dryness or scale, desquamation, erythema, papules, scratch mark, feeling of stimulation and pruritus. * Changes over time of the quantity of stratum corneum water content and transepidermal water loss between screening visit, after two weeks visit and after four weeks visit.

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	Examination on screening visit - Use the test sample on the whole body for two weeks - Examination such as observation and measurement on after two weeks visit - Use the test sample on the whole body for two weeks - Examination such as observation and measurement at after four weeks visit
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	Subjects who is satisfying all of the following criteria. 1)Healthy babies (male and female) aged 28 days-old to 11 months-old. 2)Subjects' protectors (parents or guardians) who are able to show their willingness of participating to the test, and to sign the consent form after understanding details of the test. 3)Subjects and their protectors who can manage in persion visit for all required visits.
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 be exposed to many quantity of sunlight during implementing the test. 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 medical history of serious liver dysfuction, kidney dysfuction and myocardial infarction. 10)Subject who are visiting the hospital regulary for receiving the medical treatment due to the diseases. 11)Subjects who have their family they are working at cosmetic companies and pharmaceutical companies. 12)Others, subjects who have been determined that he/she is ineligible by investigators.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Yamaguchi
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name	R&D Department
Zip code	103-8234
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	1st name Kanako Middle name Last name Sakurai
Organization	Inforward, inc
Division name	EBISU skin research center
Zip code	150-0013
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	CliniPro Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	General Incorporated Association Clinical Research Review Center
Address	2972-8-603, Ishikawamachi, Hachioji-chi, Tokyo, Japan
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.jp

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	2021 Year 08 Month 06 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	2019 Year 09 Month 02 Day
Date of IRB	2019 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 02 Month 06 Day
Last follow-up date	2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 10 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043608