UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness and elasticity
Title of the study (Brief title)	A study for the skin moisturizing effect of a dietary supplement intake
Region	Japan

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

Objectives
Narrative objectives1	A study for the skin moisturizing effect of a dietary supplement intake for 12 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stratum corneum water content (4, 8, and 12 weeks after a dietary supplement intake)
Key secondary outcomes	Transepidermal water loss, skin elasticity, collagen score, and questionnaires (4, 8, and 12 weeks after a dietary supplement intake)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Intake of test food (high dose) for 12 consecutive weeks
Interventions/Control_2	Intake of test food (low dose) for 12 consecutive weeks
Interventions/Control_3	Intake of placebo for 12 consecutive 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	45 years-old <=
Age-upper limit	64 years-old >=
Gender	Female
Key inclusion criteria	1. Females between the ages of 45 and 64 2. Subjects who are aware of skin dryness, elasticity and lower level of Stratum corneum water content
Key exclusion criteria	1. Subjects who usually take some drugs, functional foods, or cosmetics including active ingredients 2. Subjects who usually take some drugs, functional foods, etc. which would affect skin condition 3. Subjects who got some cosmetic surgery, or hormone therapy which would affect the target skins 4. Subjects who plan to have ultraviolet exposure within a month before the screening test 5. Subjects who wash the body providing strong skin irritation 6. Subjects who usually use bath additives 7. Subjects who have the wounds or inflammatory diseases which would affect the target skins 8. Subjects who have the wounds or inflammatory diseases which would affect the target skins 9. Subjects who might have allergic symptoms (pollinosis, etc.) and use medicines in this study 10. Subjects who feel skin roughness on the target skins around a menstruates 11. Subjects who employ on a pre-dawn shift or on night duty more than 2 times in this study 12. Subjects who are plan to go overseas 13. Subjects who have asthma or would have asthma during this study 14. Subjects who have severe diseases or diseases which affect a secretion of sex hormones 15. Subjects who are at risk of having allergic reaction related to this study 16. Subjects who have diseases which affect this study 17. Subjects who judged as unsuitable based on the results of clinical and physical examination 18. Subjects who participated other clinical trial within 3 months prior to this study or plan to participate other clinical trial after acquiring consent to this study 19. Pregnant or lactating women 20. Subjects who are judged as unsuitable for this study by the principal investigator
Target sample size	45

Research contact person
Name of lead principal investigator	Sumio Kondo
Organization	Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name	Internal Medicine,Department of Neurosurgery
Address	2-12-16 Tamagawa, Fukushima-ku, Osaka-shi, Osaka
TEL	06-6441-6848
Email	ko293434@ares.eonet.ne.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co., Ltd
Division name	Clinical Research Planning Department
Address	1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	not open to the public
Organization
Division
Category of Funding Organization	Profit organization
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 01 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 12 Day
Anticipated trial start date	2017 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 01 Month 21 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029658