UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046264
Receipt number R000052776
Scientific Title A Study on the Effect of Food Containing Plant Extract on skin function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2021/12/03
Last modified on 2023/06/14 16:39:35

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Basic information

Public title

A Study on the Effect of Food Containing Plant Extract on skin function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Acronym

A Study on the Effect of Food Containing Plant Extract on skin function

Scientific Title

A Study on the Effect of Food Containing Plant Extract on skin function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Scientific Title:Acronym

A Study on the Effect of Food Containing Plant Extract on skin function

Region

Japan


Condition

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effect of food containing plant extract on skin function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin viscoelasticity, Skin moisture content

Key secondary outcomes

Other skin function markers, etc.


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Foods containing plant extract, 8 weeks consumption

Interventions/Control_2

Foods not containing plant extract, 8 weeks consumption

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

30 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

1)Healthy females aged 30 to 49 years-old.
2)Subjects who are aware of skin dryness.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

Subjects(who)
1)regularly use medications or supplements affecting skin.
2) with skin disease, such as atopic dermatitis or with strange skin conditions at measurement points.
3)with severe hay fever symptoms and had been allergic symptoms of face.
4)have any food allergies.
5)contract or are under treatment or use medications for serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
6)had been conducted an operation or beauty treatment on the test spot or had been received hormone replacement therapy in the past 6 months.
7)can't avoid direct sunlight exposure, such as sunburn or sports during test periods.
8)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
9)are pregnant or planning to become pregnant or breastfeed.
10)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent and a habit of drinking not less than 4 days a week.
11)are shiftworker and/or midnight-shift worker.
12)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
13)are judged as unsuitable for the current study by the investigator for other reasons.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Kayoko
Middle name
Last name Numano

Organization

Ebisu Ray Clinic, Shinkoukai Medical Corporation

Division name

Dermatology

Zip code

150-0013

Address

1-11-2 Ebisu, Shibuya-ku, Tokyo

TEL

03-6277-3917

Email

kaco@yahoo.co.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

eigyou27@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TOYO SHINYAKU Co., Ltd.

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

General Incorporated Association Clinical Research Review Center

Address

2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo

Tel

090-3547-6398

Email

crrctakashima@kpd.biglobe.ne.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 03 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000052776

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/50120/2257

Number of participants that the trial has enrolled

70

Results

Statistically significant difference was confirmed in the Skin viscoelasticity.
Statistically significant difference was not confirmed in the Skin moisture content.

Results date posted

2023 Year 06 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Females aged 30 to 49 years old.

Participant flow

Enrolled(n=70)
Completed(n=68)
Analysed(n=61)

Adverse events

No adverse events were observed that be related to test food.

Outcome measures

Skin viscoelasticity
Skin moisture content

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2021 Year 10 Month 21 Day

Date of IRB

2021 Year 11 Month 24 Day

Anticipated trial start date

2021 Year 12 Month 04 Day

Last follow-up date

2022 Year 03 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 02 Day

Last modified on

2023 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name