UMIN-CTR Clinical Trial

Public title

A using test for four continuous weeks of SC1722 against babies

Acronym

A using test for four continuous weeks of SC1722 against babies

Scientific Title

A using test for four continuous weeks of SC1722 against babies

Scientific Title:Acronym

A using test for four continuous weeks of SC1722 against babies

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tomohiko Yamaguchi

Organization

DAIICHI SANKYO HEALTHCARE CO., LTD.

Division name

R&D Department

Zip code

Address

3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN

TEL

03-5255-6336

Email

yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

Name of contact person

1st name
Middle name
Last name	Kanako Sakurai

Organization

Inforward, inc

Division name

EBISU skin research center

Zip code

Address

1-11-2 Ebisu Shibuya-ku, Tokyo 150-0013, JAPAN

TEL

03-5793-8712

Homepage URL

Email

sakurai@inforward.co.jp

Institute

Inforward, inc
EBISU skin research center

Institute

Department

Personal name

Organization

DAIICHI SANKYO HEALTHCARE CO., LTD.
R&D Department

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medimate Co., Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社インフォワード Inforward, inc

Date of disclosure of the study information

2019

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

12

Month

15

Day

Date of IRB

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

Other related information

Registered date

2018

Year

04

Month

20

Day

Last modified on

2018

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036871