UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patch test of skin external preparations.
Title of the study (Brief title)	Patch test of skin external preparations.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the primary skin irritation of the skin external preparations.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin reactions immediately, 1day, and 7days after 48h skin external preparations patch.
Key secondary outcomes

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	48h-closed patch of 6 kinds of skin external preparations on the inner upper arm.
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	-Healthy men and women.
Key exclusion criteria	-The person who has medical treatment. -The person who has any allergies. -The person who has an experience of allergy by any drugs or cosmetics. -Pregnant woman or suspicion of pregnancy. -The person who has extensive eczema or sores in their test area (inner upper arm). -The person who judged as unfit for this test by P.I. or the parties concerned.
Target sample size	10

Research contact person
Name of lead principal investigator	Shoichiro Yano
Organization	Yaesu Nihonbashi Skin Clinic
Division name	Director
Address	1-5-17, Yaesu, Chuo-ku, Tokyo, 103-0028, JAPAN
TEL	03-6202-1200
Email	yanosyo-tky@umin.ac.jp

Public contact
Name of contact person	Shoichiro Yano
Organization	Yaesu Nihonbashi Skin Clinic
Division name	Director
Address	1-5-17, Yaesu, Chuo-ku, Tokyo, 103-0028, JAPAN
TEL	03-6202-1200
Homepage URL
Email	yanosyo-tky@umin.ac.jp

Sponsor
Institute	Yaesu Nihonbashi Skin Clinic
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	やえす日本橋ヒフ科（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry	2016 Year 04 Month 17 Day
Date trial data considered complete	2016 Year 04 Month 17 Day
Date analysis concluded	2016 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025132