UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of intake of collagen peptides in increasing skin moisture content
Title of the study (Brief title)	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	Masashi Ogo
Organization	Siseido Co., Ltd.
Division name	Global Innovation Center
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	Kazunori Takashima
Organization	Inforward, Inc
Division name	Ebisu Skin Research Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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