UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030375 |
|---|---|
| Receipt number | R000034677 |
| Scientific Title | Clinical evaluation of intake of collagen peptides in increasing skin moisture content |
| Date of disclosure of the study information | 2017/12/13 |
| Last modified on | 2017/12/13 12:04:36 |
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Basic information
Public title
Clinical evaluation of intake of collagen peptides in increasing skin moisture content
Acronym
Clinical evaluation of intake of collagen peptides in increasing skin moisture content
Scientific Title
Clinical evaluation of intake of collagen peptides in increasing skin moisture content
Scientific Title:Acronym
Clinical evaluation of intake of collagen peptides in increasing skin moisture content
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of improvement skin moisture content after the consumption of a test food in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water content at 0, 4, 8, 12 weeks after the intake
Key secondary outcomes
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
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food (1 g a day for 12 weeks)
Interventions/Control_2
Test food (5 g a day for 12 weeks)
Interventions/Control_3
Placebo food (12 weeks)
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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
A person who is a healthy person who does not fall under the following exclusion criteria and whose age at the time of consent acquisition date is from 35 years old to under 50 years old and who give written informed consent
1) Individuals who considered that they had dry skin
2) Individual who considered that they had decreased skin elasticity
3) Individuals who agreed to abstain from drinking alcohol from the day before measurement to the end of measurement
4) Individuals who agreed to participate in the study
Key exclusion criteria
1) Individuals who habitually use medicines, collagen-containing supplement, skin supplement, or slimming aid
2) Individuals with skin abnormalities at the sites to be tested
3) Patients with food allergies
4) Individuals who had received cosmetic medical treatment at the sites to be tested
5) Individuals who had received facial treatment within 1 month before the start of the study
6) Individuals with chronic conditions such as atopic dermatitis
7) Patients receiving drug therapy as outpatients
8) Habitual smokers
9) Patients with asthma
10) Individuals taking or intending to take drugs for pollinosis
11) Pregnant woman, woman desiring to become pregnant, or lactating woman
12) Individuals who had participated in other studies within the previous 3 months
13) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ogo |
Organization
Siseido Co., Ltd.
Division name
Global Innovation Center
Zip code
Address
2-2-1, Hayabuchi, Tsuzuki-ku, Yokohama, Kanagawa, 224-8558 Japan
TEL
045-590-6000
masashi.ogo@to.shiseido.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Takashima |
Organization
Inforward, Inc
Division name
Ebisu Skin Research Center
Zip code
Address
1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL
03-5447-6411
Homepage URL
takashima@inforward.co.jp
Sponsor or person
Institute
Siseido Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 13 | 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
| 2015 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 05 | Month | 19 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2017 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034677
