UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034963 |
|---|---|
| Receipt number | 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 | 2019/12/23 11:26:42 |
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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 | 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
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
imai@kt-medical.co.jp
Sponsor or person
Institute
KT Medical Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039866
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