UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, double-blind, placebo-controlled parallel-group superiority study on the skin function index of ingredient obtained from plant in healthy adult females
Acronym	A randomized, double-blind, placebo-controlled parallel-group superiority study on the skin function index of ingredient obtained from plant in healthy adult females
Scientific Title	A randomized, double-blind, placebo-controlled parallel-group superiority study on the skin function index of ingredient obtained from plant in healthy adult females
Scientific Title:Acronym	A randomized, double-blind, placebo-controlled parallel-group superiority study on the skin function index of ingredient obtained from plant in healthy adult females
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate efficacy of food containing ingredient obtained from plant for skin function of healthy females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Index for skin conditions (Skin moisuture content, Transepidermal water loss, Skin viscoelasticity)
Key secondary outcomes	Observation for skin condition Collagen Score (measuring with ultrasonic waves) Subjective symptoms for skin condition (VAS) POMS

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test food (2 capsules/day, 12 weeks)
Interventions/Control_2	Intake of control food (2 capsules/day, 12 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	30 years-old <=
Age-upper limit	55 years-old >
Gender	Female
Key inclusion criteria	Japanese adult female aged from 30 to 54 years old at time of informed consent was provided
Key exclusion criteria	1) Individuals who use regularly cosmetology or food affecting the skin condition 2) Individuals who have skin disease, or whose skin have an abnormality requiring treatment, or who have disease with affecting skin condition 3) Individuals who need to wear masks or to blow their nose due to allergic rhinitis or individuals who maybe develop the allergy during the study 4) Individuals who have chronic disease 5) Individuals with serious disorders or individuals with histories of serious disorders 6) Individuals who excessively take alcohol 7) Individuals who is smoker (smoking over 20 cigarettes/day) 8) Individuals who have a history of serious drug allergy or serious food allergy 9) Individuals who are pregnant or Individuals who are willing to become pregnant or lactation during this study 10) Individuals who are participating in other clinical trials or individuals who participated in other clinical trials within 1 month 11) Any Individuals considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Mamoru Middle name Last name Hanyuuda
Organization	Breast Health Clinic
Division name	Breast Health Clinic
Zip code	103-0025
Address	3-8-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan
TEL	03-6667-0345
Email	imai@kt-medical.co.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	KT Medical Corporation
Division name	Food clinical trial division
Zip code	100-0005
Address	6F 2-2-3 Marunouchi,Chiyoda-ku, Tokyo, Japan
TEL	03-6667-0345
Homepage URL
Email	imai@kt-medical.co.jp

Sponsor
Institute	KT Medical Corporation
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Dermatology, Wakayama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Conference of Clinical Research
Address	2-27-17 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.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	ブレストヘルスクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 23 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	Completed
Date of protocol fixation	2018 Year 11 Month 22 Day
Date of IRB	2018 Year 11 Month 22 Day
Anticipated trial start date	2018 Year 12 Month 16 Day
Last follow-up date	2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 21 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039866