UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on skin of healthy Japanese women
Acronym	Effects of consumption of the test food on skin of healthy Japanese women
Scientific Title	Effects of consumption of the test food on skin of healthy Japanese women: A randomized, double-blind, placebo-controlled comparison trial
Scientific Title:Acronym	Effects of consumption of the test food on skin of healthy Japanese women
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 on skin in healthy Japanese women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured values of scoring of R7* at 12 weeks after consumption (12w)
Key secondary outcomes	1. The amount of change of R7 between screening (before consumption; Scr) and 12w 2. The measured values and amount of change from Scr of the following items at 12w: R1, R2, R3, R4, R5, R6, R8, R9*, moisture of the skin surface, transepidermal water loss, the score of advanced glycation end products (AGEs) and Visual Analog Scale (VAS: skin moisture, eye and mouth dryness, crow's feet, skin brightness, skin dullness, skin elasticity, skin viscoelasticity, makeup condition, condition of facial pores, skin glossiness, and skin color), pentosidine, and Carboxymethyllysine (CML) 3. The measured values of microscope values (facial pores, melanin/stains, wrinkles, porphyrin/sebum prediction, and corneum) at 12w 4. The ratio of subjects who were assessed as "vastly improvement", "improvement", "slightly improvement" about skin color, skin dullness, and skin transparency in Doctor's observation *R1~R9 are defined as below: R1 (the ability of the skin to return to its original state), R2 (the ratio of the resistance to mechanical force versus the ability of recovery), R3(maximum amplitude of the last curve), R4 (minimum amplitude of the last curve), R5 (the ratio of the elastic part of the suction phase versus the immediate recovery during the relaxation phase), R6 (portion of visco-elasticity on the elastic part of the curve), R7 (portion of elasticity compared to complete curve), R8 (total recovery of the first curve), R9 (tiring effects of the skin after repeated sucking)

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: Food containing rice bran extract Administration: Take two tablets per day after breakfast with water * Daily dose should be taken within 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: Food not containing rice bran extract Administration: Take two tablets per day after breakfast with water * Daily dose should be taken within 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. Japanese 2. women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are anxious about viscoelasticity of the skin 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively few viscoelasticity of the cheek at Scr
Key exclusion criteria	Subjects (who) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. have been diagnosed with atopic dermatitis 5. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. currently taking medications (including herbal medicines) and supplements 7. allergic to medications and/or the test-food-related products (especially rice bran) 8. have got cosmetic surgery 9. habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 10. use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare 11. lifestyle is not constant and may change during test period (e.g., night shifts, business trip, travel) 12. have been overexposed to the sun within the last month, are going to be overexposed to the sun without protection, or can not prevent sunburn during this trial (from the agreement to participate in this trial to the final test) 13. plan to have surgery from first consumption to two weeks after last consumption 14. are pregnant, lactation, or planning to become pregnant 15. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 16. are judged as ineligible to participate in the study by the physician
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Izumi
Organization	Hiroo Dermatology Clinic & Mentors inc.
Division name	Director
Zip code	150-0012
Address	1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-5795-1112
Email	dr_izumi@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	NOF CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroo Dermatology Clinic & Mentors inc. 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	広尾皮フ科クリニック (東京都) Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan) 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	2021 Year 06 Month 23 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	14
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	2021 Year 06 Month 16 Day
Date of IRB	2021 Year 06 Month 16 Day
Anticipated trial start date	2021 Year 06 Month 24 Day
Last follow-up date	2021 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 21 Day
Last modified on	2022 Year 04 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050958