UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030375
Receipt No. 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

* 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 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
Email 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
Email takashima@inforward.co.jp

Sponsor
Institute Siseido Co., Ltd.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.