UMIN-CTR Clinical Trial

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

Assessment
Primary outcomes	The measured value of viscoelasticity of the skin (cheek) (R7) at eight weeks after consumption.
Key secondary outcomes	1. The measured value of viscoelasticity of the skin (cheek) (R7) at four weeks after consumption. 2. The measured values and change values from screening and advance examination of the following items at four and eight weeks after consumption: viscoelasticity of the skin (cheek) (R1, R2, R3, R4, R5, R6, R8 and R9), viscoelasticity of the skin (upper arm), moisture of the skin (cheek and upper arm), transepidermal water loss (cheek and upper arm), intensity of cheek, skin thickness of cheek, low echologenic band (LEB) of cheek, score of advanced glycation end products (AGEs) of middle finger, "skin moisture", "skin roughness", "skin texture", "sagging of the skin", "skin elasticity", "viscoelasticity of the skin", "makeup condition", "skin redness", "wrinkles", pentosidine, carboxy methyl lysine (CML) and 3-deoxyglucosone (3-DG)

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: Eight weeks Test food: Plant extract Administration: Take two capsules, once a day after breakfast. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: Eight weeks Test food: Placebo Administration: Take two capsules, once a day after breakfast. *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 viscoelasticity of the facial skin 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively low viscoelasticity of the skin (cheek) before screening and advance examination
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. 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. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning 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 cosmetic creams, beauty essence, all-in-one cosmetic makeup, face masks, skin lotions, milky lotions, and sunscreen, for daily skincare 12. Subjects who have been diagnosed with atopic dermatitis 13. Subjects who may change their lifestyles (e.g., working late-night shift, taking a long trip) during the study 14. Subjects who cannot refrained from exposure to direct sunlight such as sunburn intentionally during the study 15. 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 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	planning-department@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	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. 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 09 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	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 09 Month 15 Day
Date of IRB	2020 Year 09 Month 15 Day
Anticipated trial start date	2020 Year 09 Month 24 Day
Last follow-up date	2021 Year 01 Month 16 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 09 Month 24 Day
Last modified on	2021 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047802