UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis
Acronym	Efficacy of a skin moisturizer on atopic dermatitis
Scientific Title	Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis
Scientific Title:Acronym	Efficacy of a skin moisturizer on atopic dermatitis
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of a new skin moisturizer on atopic dermatitis patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical scores assessed by severity classification of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at the test site.
Key secondary outcomes	1) Score of skin symptoms 2) Water content 3) Trans-epidermal water loss 4) VAS 5) Skindex-16

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	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply about 1.25 g, 2.5 FTU, of the test moisturizer for face and neck skin twice a day for approximate four weeks. Apply about 2 g, 4 FTU, of the test or control moisturizer for right or left upper extremity skin twice a day for approximate four weeks, respectively.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Adults who live in the suburbs of Tokyo 2)Adults who understand Japanese Language 3)Atopic dermatitis patients with mild to moderate severity on upper extremity, face, and neck.
Key exclusion criteria	1)Atopic dermatitis patients with severe severity on upper extremity, face, and neck areas diagnosed by a dermatological doctor. 2)Patients who were diagnosed with atopic dermatitis and treated by a doctor within 3 months. 3)Patients who use medicine at test site and deemed inappropriate to stop using a drug by the principal doctor. 4)People who take part in another tests of monitors about cosmetics, quasi drugs and drug within 3 months. 5)Pregnancies and lactations and lactating women, women less than six months from childbirth. 6)People who were practiced esthetic massage or skin peeling at test area within 2 weeks. 7)People who have tattoo in face or upper extremity area. 8)Dementia patients 9)Pepole who involved in this test. 10)Employee of cosmetics, quasi drugs or drugs company. 11)Subjects deemed inappropriate to participate in this study by a dermatologist.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kaizu Kazuhiro
Organization	Kao Corporation
Division name	Skin Care Products Research
Zip code
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL	+81-465-34-0559
Email	kazuhiro.kaizu@kao.com

Public contact
Name of contact person	1st name Middle name Last name Kazunori Takashima
Organization	INFORWARD inc.
Division name	EBISU Skin research center
Zip code
Address	1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL	03-5793-8712
Homepage URL
Email	takashima@inforward.co.jp

Sponsor
Institute	INFORWARD inc.
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	KU-2017-01-007
Org. issuing International ID_1	Inforward, inc.EBISU skin research center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社インフォワード　恵比寿スキンリサーチセンター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 27 Day
Date of IRB	2017 Year 12 Month 27 Day
Anticipated trial start date	2018 Year 01 Month 19 Day
Last follow-up date	2018 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 16 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035147

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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