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

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 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


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

Value
https://center6.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