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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034340
Receipt No. R000039116
Scientific Title A study for the effect of the intake of a test food on condition of skin.
Date of disclosure of the study information 2018/10/18
Last modified on 2019/04/01

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Basic information
Public title A study for the effect of the intake of a test food on condition of skin.
Acronym A study for the effect of the intake of a test food on condition of skin.
Scientific Title A study for the effect of the intake of a test food on condition of skin.
Scientific Title:Acronym A study for the effect of the intake of a test food 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 Measurement of skin condition
(measurement time: 0, 4, 8weeks after ingestion of the test food)
Key secondary outcomes -Evaluation by a questionnaire
-Visual evaluation
(measurement time: 0, 4, 8weeks after ingestion of the test food)

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of placebo food for 8 weeks
Interventions/Control_2 Oral intake of active food for 8 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 dry skin.
3. Subjects who worries about a face becoming red in winter
4. Subjects who have sensitive skin awareness
5. Menstrual cycle is stable.
6. BMI is from 18.5 to 25.0
Key exclusion criteria 1. Subjects who are outpatients or were treated by doctor recently.
2. Subjects who take medicine (example: sleeping pills, anti-allergic drugs, hormone drugs, laxative, antiflatulent, and other medicines)
3. Subjects who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.)
4. Subjects who have severe allergic disease as pollen allergy, rhinitis, atopic dermatitis.
5. Subjects who have possibilities for emerging allergy to foods and cosmetics.
6. Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
7. Current smoker
8. Subjects who are participate in the other clinical studies
9. 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
Middle name
Last name Kumiko Ito M.D.
Organization Medical Corporation Association Ouryokukai Nihonbashi Sakura Clinic
Division name Director
Zip code
Address Inamura Building 5th Floor 1-9-2 Kayabacho, Nihonbashi, Chuo-ku Tokyo 103-0025
TEL +81-3-6661-9061
Email k-ito@ouryokukai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Naganuma
Organization DRC Co., Ltd.
Division name Product Testing Department
Zip code
Address No.9 Tabuchi Bldg. 5F, 2-10-31, Higashi-Temma, Kita-ku, Osaka, JAPAN
TEL +81-6-6882-1130
Homepage URL
Email naganuma@drc-web.co.jp

Sponsor
Institute DRC Co., Ltd.
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
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 DRC株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 18 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 09 Month 19 Day
Date of IRB
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 11 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 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 10 Month 01 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039116

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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