UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of the intake of a plant extracts containing drink on condition of skin.
Acronym	A study for the effect of the intake of a plant extracts containing drink on condition of skin.
Scientific Title	A study for the effect of the intake of a plant extracts containing drink on condition of skin.
Scientific Title:Acronym	A study for the effect of the intake of a plant extracts containing drink on condition of skin.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the effects of intake of the test food on skin conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation by a questionnaire (measurement time: 0, 2, 4, 5weeks after ingestion of the test drink)
Key secondary outcomes	Measurement of skin condition (measurement time: 0, 2, 4weeks after ingestion of the test drink)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of placebo drink for 4 weeks
Interventions/Control_2	Oral intake of active drink for 4 weeks
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	39 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy female aged from 20 to 39 years old 2. Subjects who have a dry skin trouble in arm. 3. Subjects who has atopic disposition, but they are not diagnosed as atopic dermatitis 4. Menstrual cycle is stable 5. Subjects who can forbid intaking supplements.
Key exclusion criteria	1. Subjects who have been suffered from bronchial asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis 2. Subjects who have the rash resulting from psoriasis or skin allergy 3. Subjects who are outpatients or were treated by doctor recently. 4. Subjects who are using external preparations and/or moisturizer for face, cubital fossa, forearm, popliteal space, leg and neck 5. Subjects who take medicine 6. Subjects who have skin disorder, suntan, abrasion and tattoo in face, cubital fossa, forearm, popliteal space, leg and neck 7. Subjects who have received or forbid cosmetic medicine in face, cubital fossa, lower arm, popliteal space, leg and neck 8. Subjects who have possibilities for emerging allergy to foods and drugs. 9. Subjects who are pregnant or lactating, or planned to become pregnant in the near future. 10. Current smoker 11. Subjects who are participate in the other clinical studies 12. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akane Middle name Last name Suma
Organization	Kao Corporation
Division name	Skin Care Products Research
Zip code	131-8501
Address	2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	81-3-5630-9581
Email	suma.akane@kao.com

Public contact
Name of contact person	1st name Kanako Middle name Last name Sakurai
Organization	INFORWARDinc.
Division name	EBISU Skin research center
Zip code	131-8501
Address	1-11-2 5F,Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL	81-3-5793-8712
Homepage URL
Email	sakurai@inforward.co.jp

Sponsor
Institute	Inforward Inc.
Institute
Department

Funding Source
Organization	Kao Corporation
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 Research Review Center
Address	2972-8-603 Ishikawamachi Hachioji-shi,Tokyo,192-0032,JAPAN
Tel	81-426-48-4368
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	株式会社インフォワード（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 28 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	40
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	2019 Year 10 Month 09 Day
Date of IRB	2019 Year 10 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 28 Day
Last follow-up date	2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 23 Day
Last modified on	2020 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043728