UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's Skin
Title of the study (Brief title)	Examination of Relevance of Indexes Concerning on Evaluation for Texture, Tightness and Slack of Adault Female's 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 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

Assessment
Primary outcomes	Indexes for evaluating skin condition (the test day [1 day])
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kenichi Takano
Organization	DRC Co., Ltd.
Division name	President
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

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Development for Clinical Trials
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

Sponsor
Institute	Society for Evaluation of the Skin
Institute
Department

Funding Source
Organization	Society for Evaluation of the Skin
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Examination of Relevance of Indexes Concerning on Skin.

Management information
Registered date	2017 Year 05 Month 28 Day
Last modified on	2017 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031537