UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042493
Receipt number R000048507
Scientific Title A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition
Date of disclosure of the study information 2020/11/18
Last modified on 2021/11/19 09:04:06

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Basic information

Public title

A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition

Acronym

Examination of improvement effect of skin functions

Scientific Title

A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition

Scientific Title:Acronym

Examination of improvement effect of skin functions

Region

Japan


Condition

Condition

Healthy adult female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of test food for 12 weeks on the skin's moisturizing function as a placebo control

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Water content of stratum corneum

Key secondary outcomes

Transepidermal water loss
VISIA
Skin condition questionnaire


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of 3 grain of test food per day for 12 consecutive weeks

Interventions/Control_2

Intake of 3 grain of placebo food per day for 12 consecutive 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

30 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Healthy females aged over thirty
2. Subjects who are aware of skin dryness and have low level of water content of stratum corneum

Key exclusion criteria

1.constantly take food, medicine, and etc. that contain the ingredient involved in this study
2.has skin liable to change their condition by wearing a mask, and who could not wear the mask distributed during the study period
3.constantly take food, medicine, and etc. which affects skin condition
4.had a cosmetic surgery which affects the condition of the targeted skin region
5.had a cosmetic surgery or a hormone therapy which affects the condition of the untargeted skin region within 1 year before the screening test
6.had an esthetic treatment within 1 month before the screening test, or who is planning to do so during the study period
7.had long-term sunlight exposure within 1 month before the screening test, or who have a plan to do so during the test period
8.is in the habit of washing up strongly
9.usually use bath additives
10.have wounds or inflammatory diseases which would affect the condition of the targeted skin region
11.have allergic diseases such as hay fever and atopic dermatitis
12.feel roughness on the targeted skin region during the menses period
13.work hours are irregular
14.are planning to go overseas during the study period
15.have asthma or have the possibility to develop asthma during this study
16.have serious diseases or medical history
17.have the possibility to show allergic reaction by consumption the test food
18.have diseases under treatment which affects this study, or who have medical history of serious disease requiring medication
19.are judged inappropriate for the study according to the results of the screening test
20.have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
21.are pregnant or lactating, or planning to become pregnant or lactate during this study
22.are judged as unsuitable for the study due to lifestyle questionnaire
23.are judged as unsuitable for the study by investigator for other reasons

Target sample size

64


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Akagi

Organization

Fujicco Co., Ltd.

Division name

R&D Laboratories

Zip code

650-8558

Address

6-13-4, Minatojima-nakamachi, Chuo-ku, Kobe-shi, Hyogo

TEL

078-303-5385

Email

r-akagi@fujicco.co.jp


Public contact

Name of contact person

1st name Kaori
Middle name
Last name Yoshimura

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

k.ishida@ttc-tokyo.co.jp


Sponsor or person

Institute

FUJICCO Co., Ltd., Daicel Corporation

Institute

Department

Personal name



Funding Source

Organization

FUJICCO Co., Ltd., Daicel 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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

saito876@eps.co.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

2020 Year 11 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

70

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

2020 Year 11 Month 12 Day

Date of IRB

2020 Year 11 Month 12 Day

Anticipated trial start date

2020 Year 11 Month 19 Day

Last follow-up date

2021 Year 04 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

2020 Year 11 Month 18 Day

Last modified on

2021 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048507


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name