UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045485 |
|---|---|
| Receipt number | R000051925 |
| Scientific Title | 4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products |
| Date of disclosure of the study information | 2021/09/14 |
| Last modified on | 2022/01/07 13:58:19 |
* 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
4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products
Acronym
4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products
Scientific Title
4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products
Scientific Title:Acronym
4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjects are taken a test or control product to assess the effect of the test product on skin and intestinal environmental improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Percutaneous water evaporation
Key secondary outcomes
Property of stool
Feeling during defecation
Volume of stool
Gut microbiota
Horny water content
Amount of sebum
Sebum flexibility
Sebum elasticity
Hydrogen ion index
Multiple peeling
Wrinkle analysis using replica images
Pore analysis using replica images
Texture analysis using replica images
Visual dullness evaluation
Visual spot evaluation
Visual evaluation of redness
Visual evaluation of acne
Visual evaluation of pore
Visual evaluation of blackheads in the pores
Visual evaluation of roughness of texture
Visual evaluation of wrinkle
Visual evaluation of rough skin
Visual evaluation of appearance tension
Visual evaluation of clarity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 1 cup of test food with water(when you like)for 4 weeks.
Interventions/Control_2
Take 1 cup of test food with water(when you like)for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese female over 20
years of age and under 60 years of age at the time of obtaining agreement.
2)Those who have skin attributes of skin type III and IV (according to Fitzpatrick's classification)
3)Healthy person who has not received any treatment
4)Those who have trouble drying their skin
5)Those who usually defecation 2-4 times/week
6)Those who can enter examinations and records by visiting the hospital on a specified date
7)Those who have received sufficient explanation of the purpose and content of the examination and have agreed to participate in the document at their own will
Key exclusion criteria
1)Those suffering from skin diseases such as psoriasis
2)Those suffering from skin diseases such as atopic dermatitis
3)Those suffering from skin diseases such as atopic dermatitis
4)Those who are taking or applying medications that may affect the test results
5)Those who have contact allergies or may show allergic symptoms
6)Those who currently attend dermatology
7)Those who have eczema, rash, sunburn, spots, scratch marks etc. at the test site
8)Pregnant or likely to be breastfeeding
9)Those with irregular lifestyle
10)Those who drink more than 20 grams of alcohol per day
11)Those who have smoking habits
12)Those who smoke more than 21 cigarettes per day
13)Those who use pharmaceuticals foods for specific health foods and other health foods
14)Those who cannot refrain from consuming food in certain health uses, functionally labeled foods, or so-called health foods during the inspection period
15)Those who cannot take test food as instructed
16)Those who have unders been subjected to chemical peel, laser treatment, light irradiation treatment, skin injection treatment or surgical treatment, etc. at the test site within 4 weeks prior to the start date of the test, or who have unders been subjected to esthetic treatment.
17)Those who are judged by the person in charge of test implementation tobe inappropriate for participating in the test.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Iwai |
Organization
Kirei Testing Labo Co., Ltd.
Division name
Head of Examinations
Zip code
135-0047
Address
3F Haseman Bldg., 2-11-6 Tomioka, Koto-ku, Tokyo , Japan
TEL
03-6695-0144
info@kirei-testing-labo.com
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
Mibyou Life Science Inc.
Division name
Clinical Trial Division
Zip code
101-0061
Address
5F Tokuei Bldg., Kanda Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science Inc.
Clinical Trial Division
Institute
Department
Personal name
Funding Source
Organization
GLART INC.
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
Address
6F DaiwaA Hamamatucho Bld., 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
きれいテストラボ株式会社 Kirei Testing Labo Co., Ltd.
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 14 | 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
28
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
| 2021 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
