UMIN-CTR Clinical Trial

Basic information
Public title	A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Acronym	A study for the skin moisturizing effect of a beverage intake
Scientific Title	A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Scientific Title:Acronym	A study for the skin moisturizing effect of a beverage intake
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and skin moisturizing effect of intake of test food for 8 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stratum corneum water content
Key secondary outcomes	Transepidermal water loss VISIA

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of 2 test foods per day for 8 consecutive weeks
Interventions/Control_2
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	64 years-old >=
Gender	Female
Key inclusion criteria	1.Healthy females from 20 to 64 years of age 2.Subjects who are aware of skin dryness and lower level of Stratum corneum water content
Key exclusion criteria	Subjects 1.who usually drink hard water or mineral water 2.who usually take some foods, drugs, functional foods, etc. which would affect skin condition 3.who got some cosmetic surgery which would affect the target skins 4.who got some cosmetic surgery, or hormone therapy which would affect the Other than target skins within 1 year before the screening test 5.who got esthetic treatments would affect the target skins within 1 month before the screening test, or plan the act 6.who plan to have ultraviolet exposure within 1 month before the screening test 7.who wash the body using a nylon towel, etc. which provides strong skin irritation 8.who usually use bath additives 9.who have the wounds or inflammatory diseases which would affect the target skins 10.who might have symptom of pollinosis during between February to April in the past 3 years or who are expected to have allergic symptoms on the skin during this study 11.who feel skin roughness on the target skin around a menstruates 12.who employ on a pre-dawn shift or on night duty more than 2 times in this study 13.who are planning to go overseas 14.who have asthma or would have asthma during this study 15.who have or has medical history serious disease 16.who have allergic reaction related to this study or who cannot ingest carbonated beverages 17.who have disease under treatment or who have serious disease medical history requiring medication treatment affecting this study 18.who are judged inappropriate for the study according to the results of screening test 19.who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study 20.who are pregnant or lactating, or plan to become pregnant or lactate during this study 21.who are judged as unsuitable due to lifestyle questionnaire 22.who are judged as unsuitable for the study by investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasumasa Sugiura
Organization	Georgia Premium Foods
Division name	-
Zip code
Address	3-6-9, Shiba Minato-ku, Tokyo
TEL	03-6275-1023
Email	sugiura@nabeghlavi.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kyohei Hashimoto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.hashimoto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Georgia Premium Foods
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
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	2019 Year 02 Month 07 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	10
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	2019 Year 01 Month 25 Day
Date of IRB	2019 Year 01 Month 25 Day
Anticipated trial start date	2019 Year 02 Month 08 Day
Last follow-up date	2019 Year 05 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	2019 Year 02 Month 07 Day
Last modified on	2019 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040775