UMIN-CTR Clinical Trial

Public title

The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study

Acronym

The verification study for improving skin conditions

Scientific Title

The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study

Scientific Title:Acronym

The verification study for improving skin conditions

Region

Japan

Condition

Healthy Japanese adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of the test food on improving dryness and unpleasantness of skin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Moisture of the skin surface
2. Transepidermal Water Loss (TEWL)

*^1,2 Assess at 0, 4, and 8 weeks after consuming

Key secondary outcomes

1. Glossiness of the skin surface
2. Viscoelasticity of the skin
3. Skindex-16
4. The Japanese version of Dermatology Life Quality Index (DLQI)
5. Visual Analogue Scale (VAS) of
itching sensation
6. Blood test
TARC, nonspecific IgE (RIST)

*^1-6 Assess at 0, 4, and 8 weeks after consuming

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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 8 weeks
Test materials: Acacia bark extracted tablets
Administration: Take 6 tablets in the morning with water or warm water
* When you have breakfast, take the tablets after breakfast. If you forget to take the tablets, take them as soon as you remember within the day.

Interventions/Control_2

Duration: 8 weeks
Test materials: Placebo
Administration: Take 6 tablets in the morning with water or warm water
* When you have breakfast, take the tablets after breakfast. If you forget to take the tablets, take them as soon as you remember within the day.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese adults who feel discomfort (tickling) with their skin due to drying of their face and/or hands

2. Subjects who are not diagnosed with any skin disease (e.g., atopic dermatitis) and are judged as eligible to participate in the study by the principal investigator.

3. Among the subjects who passed 2., subjects whose TARC level is less than 450 pg/mL and nonspecific IgE level is less than 170 IU/mL

4. Among the subjects who passed 3., subjects whose TEWL is relatively high

Key exclusion criteria

1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Subjects who are diagnosed with restless legs syndrome

5. Subjects who have been diagnosed with atopic dermatitis

6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare.

7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

8. Subjects who have been overexposed to the sun within the last month before the agreement to participate in this trial, or are going to overexpose to the sun during this trial (from the agreement to participate in this trial to the final test)

9. Currently taking medicines (include herbal medicines) and supplements

10. Subjects who are allergic to medicines and/or the test food related products or who have allergic skins

11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant

12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

13. Subjects who are judged as ineligible to participate in the study by the principal investigator.

Target sample size

60

Name of lead principal investigator

1st name	YAMAMOTO
Middle name
Last name	Kazuo

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

141-0022

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name	SUZUKI
Middle name
Last name	Naoko

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

mimozax Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Hiroo Dermatology Clinic & Mentors inc.

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

Date of disclosure of the study information

2017

Year

07

Month

12

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

https://www.tandfonline.com/doi/full/10.1080/09168451.2018.1547626?journalCode=tbbb20

Number of participants that the trial has enrolled

66

Results

Hoshino T, Yamashita S, Suzuki N, Baba A, Ogawa S, Izumi T. Impact of Acacia bark extract tablets on the skin of healthy humans: a randomized, double-blind, placebo-controlled study. Biosci Biotechnol Biochem. 2019; 83(3): 538-550

Results date posted

2021

Year

07

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2018

Year

12

Month

10

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2017

Year

07

Month

10

Day

Date of IRB

2017

Year

07

Month

10

Day

Anticipated trial start date

2017

Year

07

Month

12

Day

Last follow-up date

2017

Year

12

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

12

Day

Last modified on

2021

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032254