UMIN-CTR Clinical Trial

Public title

Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's Skin

Acronym

Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's Skin

Scientific Title

Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's Skin

Scientific Title:Acronym

Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's Skin

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine relevance of indexes concerning on evaluation for texture, tightness and slack of adult female's cheek.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Indexes for evaluating skin condition (the test day [1 day])

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

69

years-old

>=

Gender

Female

Key inclusion criteria

[1]Individuals aged 30-69 years (the rate of smoker and nonsmoker is 1:1).
[2]Female who is healthy.
[3]Individuals who use 0-2 toner(s) or milky lotion(s) after washing.
[4]Individuals whose written informed consent has been obtained.

Key exclusion criteria

[1]Individuals whose skin of face has disorder(s), such as atopic dermatitis and hives, or inflammation, eczema, trauma, warts or these mark(s).
[2]Individuals who received cosmetic medicine (ex. injection of botox, hyaluronic acid or collagen, or photofacial).
[3]Individuals who received special skin care at a beauty salon or an esthetic salon in the past 4 weeks.
[4]Individuals who use material(s) constantly except toner(s) or milky lotion(s) such as cream, essence, all-in-one cosmetics.
[5]Individuals whose skin is sunburned excessively in the past 4 weeks.
[6]Individuals who receive a therapy to treat or prevent disease at the medical organization such as hormone replacement therapy, drug therapy, exercise therapy, or diet remedy, or are judged to receive medical treatment.
[7]Individuals who have a history of glucose metabolism, lipid metabolism, hepatopathy, kidney damage, heart disease, cardiovascular disease, respiratory disease, endocrine system disease, or Nervous system disease.
[8]Individuals who have a history of alcoholism or drug addiction.
[9]Individuals who participated other clinical trials for human subjects with cosmetics, foods, drugs, quasi-drugs, or medical equipment in the past 4 weeks.

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Takano

Organization

DRC Co., Ltd.

Division name

President

Zip code

Address

3F the 9th Tabuchi Bldg. 2-10-31 Higashi-Temma Kita-ku Osaka, 530-0044 JAPAN

TEL

06-6882-8201

Email

takano@drc-web.co.jp

Name of contact person

1st name
Middle name
Last name	Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Development for 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

t.tamura@tes-h.co.jp

Institute

Society for Evaluation of the Skin

Institute

Department

Personal name

Organization

Society for Evaluation of the Skin

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2017

Year

05

Month

28

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

2017

Year

05

Month

16

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Examination of Relevance of Indexes Concerning on Skin.

Registered date

2017

Year

05

Month

28

Day

Last modified on

2017

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031537