UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on skin condition in healthy Japanese subjects
Acronym	Effects of consumption of the test food on skin condition in healthy Japanese subjects
Scientific Title	Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym	Effects of consumption of the test food on skin condition in healthy Japanese subjects
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 six weeks on skin viscoelasticity, skin collagen concentration, skin moisture in healthy Japanese subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured value of viscoelasticity of the skin (cheek) at six weeks after consumption (6w)
Key secondary outcomes	1. The measured value of viscoelasticity of the skin (back of the hands) at 6w 2. The measured value of viscoelasticity of the skin (cheek and back of the hands) at four weeks after consumption (4w) 3. The amount of change from screening (before consumption; Scr) of viscoelasticity of the skin (cheek and back of the hands) to 4w and 6w 4. The measured value and the amount of change from Scr of transepidermal water loss (cheek), water content (cheek), and dermal measurement (cheek and back of the hands) at 4w and 6w 5. The measured value and the amount of change from Scr of visual analog scale (VAS) score (skin moisture, skin roughness, skin texture, sagging of the skin, skin elasticity, skin viscoelasticity, and makeup condition), 1,5-anhydroglucitol (1,5-AG), and glycoalbumin at 6w

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: Six weeks Test food: Capsule containing pentadecyl-containing auran oil Administration: Take one capsule with water without chewing once a day *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: Six weeks Test food: Placebo capsule Administration: Take one capsule with water without chewing once a 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	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are concerned about skin viscoelasticity 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose low echogenic band (LEB) (back of the hands) are not 0 8. Subjects whose viscoelasticity of the skin (cheek) are relatively low
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements (particularly including docosahexaenoic acid and/or eicosapentaenoic acid) 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who have been diagnosed with atopic dermatitis 8. Subjects who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare 9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 10. Subjects who have undergone cosmetic surgery 11. Subjects who are aspirin-intolerance or currently taking medications including aspirin 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who suffer from COVID-19 14. Subjects who 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 15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	52

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	Sea Act Co., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Hiroo Dermatology Clinic & Mentors inc. 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) 広尾皮フ科クリニック (東京都) Hiroo Dermatology Clinic & Mentors inc. (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	2022 Year 01 Month 24 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	56
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	2022 Year 01 Month 19 Day
Date of IRB	2022 Year 01 Month 19 Day
Anticipated trial start date	2022 Year 01 Month 25 Day
Last follow-up date	2022 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 24 Day
Last modified on	2022 Year 11 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053282