UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034340 |
|---|---|
| Receipt number | 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 17:50:15 |
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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
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
naganuma@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039116
