UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055361 |
|---|---|
| Receipt number | R000063162 |
| Scientific Title | Collection of indigenous bacteria specimens and skin measurements for infants |
| Date of disclosure of the study information | 2024/09/02 |
| Last modified on | 2024/08/29 10:53:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Collection of indigenous bacteria specimens and skin measurements for infants
Acronym
Collection of indigenous bacteria specimens and skin measurements for infants
Scientific Title
Collection of indigenous bacteria specimens and skin measurements for infants
Scientific Title:Acronym
Collection of indigenous bacteria specimens and skin measurements for infants
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe skin flora and skin condition of infants
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin flora
Key secondary outcomes
doctor's fidings
skin pH
skin hydration
transepidermal water loss
sebum amount
questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 3 years 0 months to 5 years 11 months old at the time of informed consent
2) Those who can come to the institute with their parents on the day of informed consent in order to obtain their consent
3) Those who can agree not to wash or wipe their face from the time they wake up until the end of the measurement on the day of the test
Key exclusion criteria
1) Those who have been diagnosed with atopic dermatitis
2) Those currently attending a dermatology clinic
3) Those participating in other clinical trials during the study period
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nagai |
Organization
SOUKEN Co., Ltd.
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
y_nagai@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Pigeon Home Products Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe skin flora and skin condition such as doctor's fidings, skin pH, skin hydration, transepidermal water loss, sebum amount and questionnaire of infants.
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063162
