UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for improvement of skin condition by using cosmetics
Title of the study (Brief title)	Evaluation for improvement of skin condition by using cosmetics
Region	Japan

Condition
Condition	Healthy adult female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate changes in skin condition when healthy adult female use cosmetics for 4 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of skin condition before starting use of test article and 4 weeks after use
Key secondary outcomes	subjective evaluation, safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Using cosmetic essence for 4 consecutive weeks
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	35 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	1. Subjects who worries about slack of a skin (face line,under the eyes, a cheek, pores) 2. Subjects who cares about wrinkles of the forehead
Key exclusion criteria	1. Subjects with cosmetic allergies 2. Subjects who are pregnant or lactating 3. Subjects with inflamed or scraped skin on face 4. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	20

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Email	info@yakujihou.org

Public contact
Name of contact person	Takeshi Kaneko
Organization	Japan Clinical Trial Association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	0364574666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan Clinical Trial Association
Institute
Department

Funding Source
Organization	Mirai Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 26 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

Management information
Registered date	2018 Year 02 Month 23 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035904