UMIN-CTR Clinical Trial

Basic information
Public title	Test for confirming the effect of improving complexion by ingesting the test product for 3 months
Acronym	Test for confirming the effect of improving complexion by ingesting the test product for 3 months
Scientific Title	Clinical trial for confirming the effect of improving complexion by ingesting the test product for 12 weeks
Scientific Title:Acronym	Clinical trial for confirming the effect of improving complexion by ingesting the test product for 12 weeks
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify ingestion of test food for 12 weeks on skin complexion and skin brightness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin color
Key secondary outcomes	*Secondary index [1]Observation for skin condition by dermatologists [2]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 show their intention to participate in the exam, understand the explanation, and obtain written consent to participate in the exam 2. Healthy Japanese women aged 35 to 50 who do not violate the exclusion criteria 3. Those who can fill out documents such as consent forms, questionnaires, usage diaries, etc. 4. Those who have felt the effect on the skin with supplements etc. 5. Those who are concerned about skin color 6. Those who feel a decrease in skin brightness 7. Those who feel cold (limbs, etc.) 8. Those who feel stress and anxiety every day
Key exclusion criteria	1. At the time of obtaining consent, those who regularly use supplements that claim to beautify the skin, diet supplements, collagen supplements, and medicines that may be involved in skin quality (for example, Hythiol C) 2. Those who have significant abnormalities in the skin condition of the test site (face / inside the upper arm) 3. Those with food / drug allergies 4. Those who cannot stop drinking from the day before the measurement date to the end of the measurement 5. Those who smoke on a daily basis 6. Asthma 7. Those who have experience in aesthetic medicine that affects the test site 8. Those who have received a facial treatment and have not passed more than a month 9. Those with chronic skin symptoms such as atopic dermatitis, contact dermatitis, and skin hypersensitivity 10. Those who are currently going to the hospital and using medicines 11. Those who have developed hay fever and are taking medication 12. Those who have a major surgical history in the digestive system, those who have respiratory and heart problems 13. Those who are undergoing hormone replacement therapy for menopause or who have not passed more than 6 months after treatment 14. Those who are participating in a test of ingesting other foods or drugs, or applying cosmetics or drugs, or who have participated in a similar test and have not passed more than 3 months since participating 15. Those who are extremely sunburned or who cannot avoid long hours of outdoor work or sports 16. During lactation or pregnancy,or those who wish to become pregnant during the test period 17. In addition, those who are judged to be ineligible by the investigator and the person responsible for conducting the study
Target sample size	33

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 220-0011, Japan
TEL	045-222-1600
Email	osamu.ueda@shiseido.com

Public contact
Name of contact person	1st name Motoko Middle name Last name Matsuzaka
Organization	Dermalabo Co., Ltd.
Division name	Study Support group
Zip code	060-0001
Address	1-5-2, Chuou-ku, Sapporo-shi, Hokkaido 060-0001, Hokkaido
TEL	011-205-0781
Homepage URL
Email	m.matsuzaka@dermalabo.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	Tactics, Hokkaido Revitalization Center, Specified Nonprofit Corporation
Address	2-9 Chuou-ku, Sapporo-shi, Hokkaido, 060-0000, Japan
Tel	011-281-6783
Email	yukiko.iw@gmail.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

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 08 Month 10 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 25 Day
Last follow-up date	2022 Year 12 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	2022 Year 08 Month 22 Day
Last modified on	2022 Year 08 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055440