UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035492 |
|---|---|
| Receipt number | R000040439 |
| 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 | 2019/01/18 |
| Last modified on | 2019/07/11 16:32:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Evaluation by a questionnaire
(measurement time: 0, 2, 4, 5weeks after ingestion of the test food)
Key secondary outcomes
Visual evaluation
Measurement of skin condition
(measurement time: 0, 2, 4, 5weeks 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 4 weeks
Interventions/Control_2
Oral intake of active food for 4 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 a dry skin trouble in forearm and/or cubital fossa
3. Subjects who has atopic disposition, but they are not diagnosed as atopic dermatitis
4. Menstrual cycle is stable
5. Subjects who can forbid intaking supplements.
Key exclusion criteria
1. Subjects who have been suffered from bronchial asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis
2. Subjects who have the rash resulting from psoriasis or skin allergy
3. Subjects who are outpatients or were treated by doctor recently.
4. Subjects who are using external preparations and/or moisturizer for face, cubital fossa, forearm, popliteal space, leg and neck
5. Subjects who take medicine
6. Subjects who have skin disorder, suntan, abrasion and tattoo in face, cubital fossa, forearm, popliteal space, leg and neck
7. Subjects who have received or forbid cosmetic medicine in face, cubital fossa, lower arm, popliteal space, leg and neck
8. Subjects who have possibilities for emerging allergy to foods and drugs.
9. Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
10. Current smoker
11. Subjects who are participate in the other clinical studies
12. 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 | Akane Suma |
Organization
Kao Corporation
Division name
Skin Care Products Research
Zip code
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
81-(0)3-5630-9581
suma.akane@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Sakurai |
Organization
INFORWARD inc.
Division name
EBISU Skin research center
Zip code
Address
1-11-2 5F Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL
81-(0)3-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
Inforward Inc.
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
株式会社インフォワード（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040439
