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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032333
Receipt No. R000036871
Scientific Title A using test for four continuous weeks of SC1722 against babies
Date of disclosure of the study information 2019/05/10
Last modified on 2018/11/12

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Basic information
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
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
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

Public contact
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

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)

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 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

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 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
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

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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