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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035492
Receipt No. 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

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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 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
Email 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
Email sakurai@inforward.co.jp

Sponsor
Institute Inforward Inc.
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040439

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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