UMIN-CTR Clinical Trial

Public title

A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.

Acronym

A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.

Scientific Title

A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.

Scientific Title:Acronym

A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.

Region

Japan

Condition

N/A (healthy adults or adults with obese tendencies)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of oral administration of a Koji extract on skin condition and the safety of long-term intake of the extract.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

<Efficacy>
Transepidermal water loss, skin moisture, wrinkle topography, assessment of skin condition by a skin specialist, questionnaires about skin condition.
<Safety>
Blood pressure, pulse, body weight,
body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor.

Key secondary outcomes

<Efficacy>
Color difference, melanin, erythema, image analysis of face skin by VISIA, texture of skin.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

200 mg of a Koji extract, once-daily for 12 weeks

Interventions/Control_2

200 mg of placebo, not including the Koji extract, once-daily for 12 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

Age-lower limit

30

years-old

<=

Age-upper limit

50

years-old

>

Gender

Female

Key inclusion criteria

1) Female aged from 30 to 49 years, when giving the informed consent.
2) Healthy individuals not having any chronic diseases or dermatoses.
3) Individuales who have dry skin and shallow wrinkles.
4) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5) Individuals who can accomplish their tasks in the study at the appointed date
6) Individuals who are judged suitable for this study by the investigator.

Key exclusion criteria

Individuals written in below,
-who have some diseases with drug therapy,
-who onsecutively receive medications for treatment of disease in the last 1 month,
-who have severe disease histories in liver, kidney, heart, lung, blood or other tissues,
-who have comorbidity or disease history in respiratory system,
-whose systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg, respectively,
-who have donated over 200 or 400 mL of blood in the last 1 or 3 months,
-who have severe anemia,
-who could have some allergy to the test diet, foods or medicines,
-who are pregnant, breastfeeding, or planning to be pregnant in the near future,
-who are alcoholic or have mental disorder,
-who have smoking habit,
-who have irregular defecation,
-who could change their life style during the study,
-whose skin is extremely sensitive, or who have chronic ruddy complexion, outstanding pores or freckles,
-who have some skin diseases such as atopic dermatitis,
-who could have a seasonal allergy,
-who have severe menopausal symptoms,
-who have severe poor circulation,
-who cannot care their skin enough,
-who are willing to get sunburn, spend long time outdoors during the study,
-who habitually intaked functional or healthy foods or supplements that could get skin condition better in the last 3 months, or who are planning to intake them during the study,
-who habitually consume cosmetics or foods made of Koji,
-who routinely used pharmaceuticals that could get skin condition better in the last 3 months,
-who use cosmetics that could have strong effects on skin moisture or wrinkles,
-who received a surgery on their faces or arms in the last 6 months,
-who participated in other clinical trials in the last 3 months,
-who and whose family work for a company manufacturing or selling healthy foods, functional foods or cosmetics,
-who are judged unsuitable for this study by the investigator for other reasons,

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Internal Department

Zip code

Address

4F Atago Greenhills MORI Tower, 2-5-1 Atago, Minato-ku, Tokyo, Japan

TEL

03-3432-5021

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Clinical Trial

Zip code

Address

6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-6801-8480

Homepage URL

Email

t.tamura@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社TESホールディングス肌関連試験用検査施設 (TES Holdings Inspection Facilities for Skin Tests)
医療法人社団和啓会メディクス本郷クリニック (Medical Corporation Wakei Kai MEDICS Hongo Clinic)

Date of disclosure of the study information

2017

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

10

Month

29

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

12

Day

Last modified on

2017

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022818