UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026573
Receipt number R000030471
Scientific Title Effects of the Test Product for Skin
Date of disclosure of the study information 2017/03/17
Last modified on 2017/09/15 09:20:28

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Basic information

Public title

Effects of the Test Product for Skin

Acronym

Effects of the Test Product for Skin

Scientific Title

Effects of the Test Product for Skin

Scientific Title:Acronym

Effects of the Test Product for Skin

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of the product on skin condition.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Transepidermal water loss, skin moisture content, skin viscoelasticity (Week 0, Week 8)

Key secondary outcomes

*Secondary outcomes
[1]Observation for skin condition by a specialist (Week 0, Week 8)
[2]Questionnaire of physical feeling (Week 0, Week 4, Week 8)

*Other indexes
[1]Diagnosis by doctors (Week 0, Week 8)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)


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

Oral intake of the test product (4 capsules in a day; 8 weeks)

Interventions/Control_2

Oral intake of the placebo product (4 capsules in a day; 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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

[1]Females aged 30-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are concerning on dry skin.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination in a designated day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who developed asthma in the past 3 months.
[3]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[4]Individuals with strange skin conditions at measurement points.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Individuals who are or are possibly pregnant, or are lactating.
[10]Individuals who have an addiction to alcohol or a mental illness.
[11]Individuals who are a smoker.
[12]Individuals whose bowel habit is irregular.
[13]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period.
[14]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[15]Individuals who cannot avoid daylight exposure during the test period.
[16]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[18]Individuals who use cosmetics having a strong moisturizing effect or improvingg effect for wrinkle.
[19]Individuals who had been conducted an operation on the test spot in the past 6months.
[20]Individuals who participated in other clinical studies in the past 3 months.
[21]Individuals who and whose family work in a company developing or manufacturing functional foods.
[22]Individuals judged inappropriate for the study by the principal.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Director

Zip code


Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-6801-8480

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

API 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


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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 17 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

2017 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 16 Day

Last modified on

2017 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030471


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name