UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy test of the moisturizer JI1
Title of the study (Brief title)	Efficacy test of the moisturizer JI1
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of water content, transepidermal water loss, visual score and texture after the topical application for 4, 8, 12 weeks
Key secondary outcomes	Change of cell morphology and the composition of stratum corneum after the topical application for 4, 8, 12 weeks

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the formulation including an active ingredient to the half of facial skin twice daily for 12 weeks Apply the placebo formulation to the another half of facial skin twice daily for 12 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	-Subjects with cutaneous symptoms of atopic dermatitis -Pregnancies and lactations -Subjects undergoing hormon therapy -Subjects participation in another clinical study accompanied by topical application of formulations and tape stripping or delipidation treatment to obtain experimantal dry skin to the sites to be studied within the past 1 month -Subjects deemed inappropriate to participate in this study by the parinciple investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Yukiyoshi Katsumata
Organization	EXAM CO., LTD
Division name	Cosmetic Laboratory Department
Address	H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-001, JAPAN
TEL	011-205-0781
Email	dermalabo@ekusamu.co.jp

Public contact
Name of contact person	Yukiyoshi Katsumata
Organization	EXAM CO., LTD
Division name	Cosmetic Laboratory Department
Address	H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-001, JAPAN
TEL	011-205-0781
Homepage URL
Email	dermalabo@ekusamu.co.jp

Sponsor
Institute	EXAM CO.,LTD
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
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	株式会社エクサムデルマラボ事業部（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 24 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 11 Month 30 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022715