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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034963
Receipt No. R000039866
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
Date of disclosure of the study information 2018/11/23
Last modified on 2018/11/21

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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
Middle name
Last name Mamoru Hanyuuda
Organization Breast Health Clinic
Division name Breast Health Clinic
Zip code
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
Middle name
Last name Shigeru Imai
Organization KT Medical Corporation
Division name Food clinical trial division
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 16 Day
Last follow-up date
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
2018 Year 11 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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