UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Acronym	A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Scientific Title	A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index: A randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	A verification study of the effects of consumption of ORYZA CERAMIDE on the skin barrier function using TEWL as an index
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of consumption of the test food for 12 weeks on the skin barrier function in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured values of transepidermal water loss (TEWL) of the cheek at 12 weeks after the start of test-food consumption
Key secondary outcomes	1. The measured values of TEWL of the cheek at 4and 8weeks after the start of test-food consumption 2. The amount of changes of the measured values of TEWL of the cheek between screening and at 4, 8, and 12 weeks after the start of test-food consumption 3. The measured values of the listed items at 4, 8, and 12 weeks after the start of test-food consumption 4. The amount of changes of the measured values of the listed items between screening and at 4, 8, and 12 weeks after the start of test-food consumption <the evaluation items of No. 3 and 4> moisture of the skin (cheek and lips), TEWL (scalp, upper arm, back, lips, back of the right hand), viscoelasticity of the cheek, total number of noticeable facial pores, numbers of noticeable facial pores, facial pores with prominent opening, facial pores with prominent darkening, and facial skin pigmentations (small size and large size: Lv 1), areas of facial skin pigmentations (small size and large size: Lv 1), numbers of wrinkles under the eyes (total of the both eyes, average of the both eyes, right, left), total length of crow's feet, total area of crow's feet, facial skin brightness, facial skin texture, skin oiliness, facial pores, the index of melanin and facial pigmentations, facial wrinkles, the index of porphyrin and sebum prediction, and facial corneum 5. The measured values of the questionnaire at 4, 8, and 12 weeks after the start of test-food consumption

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Capsule containing ORYZA CERAMIDE(R)-PCD Administration: Take one capsule per day at any time during the day. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test food: Placebo Administration: Take one capsule per day at any time during the day. *If you forget to take the test food, take it as soon as you remember within the 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Healthy Japanese adult women 2. Subjects who are anxious about skin moisture 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose TEWL of cheek is relatively high at screening
Key exclusion criteria	1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who have got cosmetic surgery 10. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 11. Subjects who use any other products except for general skin care products (a cream/essence, a skin pack, skin lotion, milky lotion, sunscreen, and these all-in-one products) 12. Subjects who have been diagnosed with atopic dermatitis 13. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Oryza Oil & Fat Chemical Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 08 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	44
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	2020 Year 07 Month 27 Day
Date of IRB	2020 Year 07 Month 27 Day
Anticipated trial start date	2020 Year 08 Month 04 Day
Last follow-up date	2020 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 03 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047159