UMIN-CTR Clinical Trial

Basic information
Public title	Improvement of the skin quality through the combination of foods and cosmetics
Acronym	Improvement of the skin quality through the combination of foods and cosmetics
Scientific Title	Improvement of the skin quality through the combination of foods and cosmetics
Scientific Title:Acronym	Improvement of the skin quality through the combination of foods and cosmetics
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the improvement of the skin quality from using the combination of both foods (supplement) and cosmetics (cosmetic)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for skin conditions (stratum corneum moisture content, transepidermal water loss) and questionnaire (water amount, drying)
Key secondary outcomes	score of spots, wrinkles, pores, texture, porphyrin, ultraviolet ray spot, red and brown spots, transepidermal water transpiration amount, skin elasticity, multiple peeling rate, stratum corneum cell area, oxidative stress, glycation degree, special urine Inspection and questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food Other
Interventions/Control_1	Apply test cosmetics (gel) continuously for 4 weeks
Interventions/Control_2	Apply test cosmetics (lotion, cream) continuously for 4 weeks
Interventions/Control_3	Apply test cosmetics (lotion, cream) continuously for 4 weeks, and take the test food continuously for 4 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	40 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	(1) Age range is between 40 years old and under 60 years old (2) female (3) Candidates with voluntary informed consents
Key exclusion criteria	1.Those who are allergic to the raw materials of the test food 2.Those who are taking foods stated to contain ingredients in the subject food 3.Those who are taking dietary supplements 4.Those who have skin conditions that may affect the results of the test on the skin 5.Those who have experienced skincare treatment at the evaluation site, or who are planned to receive it during the examination period 6.Those who have received special skincare treatment on the evaluation site within the past 4 weeks or are scheduled to receive during the examination period 7.Those who are continuously using skincare products or health foods that enhance the efficacy similarly to the effects being examined in this study 8.Those who have changed the skincare products or sunscreen agents used on the evaluation site within the past 4 weeks, or newly started 9.Night-shift and/or day-shift workers 10.Those who are receiving treatments at a medical institution or alike for treatment 11.Those who have a history of serious diseases or psychiatric disorders of glucose metabolism, lipid metabolism, liver function, etc. and nervous system 12.Those who have a history of alcohol and drug dependency 13.Those who are at risk of developing allergy to cosmetics and foods (including those who have developed skin abnormalities, such as rash within the past year) 14.Those who are pregnant, breast-feeding at the time of acquiring consent, or who desire pregnancy during the examination period 15.Those who have participated in other human tests within the past 4 weeks or who are planning to participate in other human examinations during the study scheduled period 16.Those who are judged by the investigator (or the person responsible for conducting the examination) to be inappropriate for participating in the examination
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name Kondo
Organization	Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name	Medical Corpoation Kenshokai Fukushima Healthcare Center
Zip code	553-0004
Address	2-12-16, Tamagawa Fukushima-ku, Osaka, Japan
TEL	81-(0)6-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Yatsuhashi
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
Zip code	555-8502
Address	4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL	+81-6-6477-8425
Homepage URL
Email	hiroko.yatsuhashi@glico.com

Sponsor
Institute	Ezaki Glico Co., Ltd.
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd.
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	Kensho-kai Institutional Review Board
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka
Tel	81-(0)6-6882-1130
Email	ethics_board@drc-web.co.jp

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	2018 Year 12 Month 11 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	34
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	2018 Year 11 Month 15 Day
Date of IRB	2018 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 12 Month 12 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 10 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040055