UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-3
Acronym	Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-3
Scientific Title	Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-3
Scientific Title:Acronym	Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-3
Region	Japan

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

Objectives
Narrative objectives1	Confirm the effect of improving skin condition, mainly skin elasticity, when taking the test product for 3 months
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin elasticity (probe 6mm)
Key secondary outcomes	*Secondary index [1] Skin elasticity (probe 2mm) [2] Wrinkle evaluation value by doctors [3]Questionnaire of physical feeling *Safety [1]Doctor's questions *Other index [1]Subject's diary

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food containing plant mixed extract A and plant mixed extract B (Tablets) for 12 weeks
Interventions/Control_2
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	35 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	1. Those who indicate their intention to participate in the test, understand the explanation, and obtain written consent to participate in the test 2. Healthy Japanese women between the ages of 35 and 50 who do not meet the exclusion criteria 3. Those who can fill in documents such as consent forms, questionnaires, test product intake diaries, etc. 4. Subjects who have felt effects on the skin with supplements, etc. 5. Subjects who feel a decrease in skin firmness 6. Mainly Grade 1 to 3 on the outer corner of the eye (Journal of the Japanese Cosmetic Science Society, 2006, Vol. 30, No. 4) Persons with wrinkles corresponding to p316-322) 7. People with dry skin 8. Those who have menopausal symptoms (any symptoms) Flushed face, sweating easily, lower back and limbs getting cold easily, shortness of breath/palpitations, difficulty falling asleep/shallow sleep, irritability and irritability, drowsiness/depression, headache/dizziness/nausea are common , Stiff shoulders, back pain, pain in limbs 9. Those who feel easily tired
Key exclusion criteria	Those who meet even one of the following conditions will be excluded. 1. Those who currently use skin care and diet supplements, collagen supplements, and pharmaceuticals on a regular basis 2. Persons who cannot abstain from drinking from the day before the measurement to the end of the measurement 3. Those who smoke on a daily basis 4. Person with asthma 5. Those who are pregnant or planning to become pregnant, those who are breastfeeding 6. Those who have hay fever (those who do not take hay fever medicine are allowed) 7. Persons with food allergies 8. Tests of ingesting other foods and drugs, and applying cosmetics and drugs who are currently participating in a similar study or who have been participating in a similar study for at least 3 months who have not passed 9. Others who are judged to be inappropriate by the principal investigator
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Ueda
Organization	Shiseido Co., Ltd.
Division name	MIRAI Technology Institute
Zip code	220-0011
Address	1-2-11, Takashima, Nishi-ku, Yokohama-shi, Kanagawa, Japan
TEL	045-222-1600
Email	osamu.ueda@shiseido.com

Public contact
Name of contact person	1st name Kanako Middle name Last name Sakurai
Organization	Inforward Co., Ltd.
Division name	Ebisu Skin Research Center
Zip code	150-0013
Address	5th floor, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL	03-5793-8712
Homepage URL
Email	sakurai@inforward.co.jp

Sponsor
Institute	Shiseido Co., Ltd.
Institute
Department

Funding Source
Organization	Shiseido Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	General Incorporated Association Crinical Rese arch Review Center
Address	2972-8-603 Ishikawamachi Hachioji-shi,Toky o,192-0032,JAPAN
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.jp

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	2025 Year 01 Month 01 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
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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date	2022 Year 11 Month 04 Day
Last follow-up date	2023 Year 03 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	2022 Year 11 Month 04 Day
Last modified on	2022 Year 11 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056275