UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The masking effect of the foundation
Title of the study (Brief title)	The masking effect of the foundation
Region	Japan

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

Objectives
Narrative objectives1	This study aims to assess the masking effect of the foundation such as smoothness and color.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before-and-after visual differences, subjective evaluations
Key secondary outcomes

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	cosmetics (foundation), adequate application (each subject use by ordinary at makeup), single foundation application
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	25 years-old <=
Age-upper limit	55 years-old >=
Gender	Female
Key inclusion criteria	1. Female between 25 and 55 years of age inclusive 2. Subjects with 1-3 grade of wrinkle according to guideline for evaluation of anti-wrinkle products by task force committee for evaluation of anti-aging function
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	10

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial association
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	Hirohisa Kojima
Organization	Japan clinical trial association
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan clinical trial association
Institute
Department

Funding Source
Organization	RISOU Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	C-TECJAPAN Co., Ltd
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	2015 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Anticipated trial start date	2015 Year 10 Month 09 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	2015 Year 10 Month 09 Day
Last modified on	2016 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022316