UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038263 |
|---|---|
| Receipt number | R000043608 |
| Scientific Title | A using test for four continuous weeks of C-271 in babies |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2021/07/27 10:27:16 |
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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
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
sakurai@inforward.co.jp
Sponsor or person
Institute
Inforward, inc
EBISU skin research center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043608
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