UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial for improving effects of test food on skins in women
Acronym	A randomized controlled trial for improving effects of test food on skins in women
Scientific Title	A randomized controlled trial for improving effects of test food on skins in women
Scientific Title:Acronym	A randomized controlled trial for improving effects of test food on skins in women
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the test food improves skins in women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Moisture content of the stratum corneum Skin elasticity
Key secondary outcomes	transepidermal water loss erythema total area of wrinkle skin texture Analysis of stains, wrinkles, pores, skin color, hidden stains using VISIA Questionnaires(VAS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: test food 1 capsules per day (258mg/day)
Interventions/Control_2	Duration: 12 weeks Test material: Placebo 1 capsules per day (258mg/day)
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	(1)Females aged 30 to 64 years old (2)Written informed is required
Key exclusion criteria	(1)These prescreened medicine. (2)These having Food for Specified Health Uses (FOSHU) and/or health food. (3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., heart, liver, kidney and/or digestive organ). (4)Pregnant women, lactating women, or women who want to get pregnant during the trial period (5)Heavy alcohol drinker. (6)Those that have extremely disheveled lifestyle and/or dietary habits. (7)Subjects who have previous medical history of drug and/or food allergy. (8)Subjects who have skin allergy such as the atopy. (9)Subjects with more than of number of cigarettes smoked an average of 21 per day (10)Subjects who have been participated in another trial or other investigational and/or enrolled in the other clinical trials within about last 1 month. (11)Subjects who have treated cosmetic care(e.g., electric facials, esthetic, peeling and/or laser medical treatment). (12)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study. (13)Subjects who have donated over 400 mL of blood and/or blood components within the last four months prior to the current study. (14)Subjects who collected blood amount of blood sampling over 800 mL within the last twelve months prior to the current study and this clinical trial's blood sampling. (15)Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Katsuhisa Middle name Last name Sakano
Organization	CPCC Co.,Ltd.
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Co.,Ltd.
Division name	Plan Sales Department
Zip code	101-0047
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Co.,Ltd.
Institute
Department

Funding Source
Organization	WAKASA SEIKATSU 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
Tel	03-2597-5548
Email	IRB@cpcc.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	2014 Year 10 Month 03 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	2014 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date	2014 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017817