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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030829
Receipt No. R000035147
Scientific Title Evaluation of the efficacy of a skin moisturizer on mild to moderate atopic dermatitis
Date of disclosure of the study information 2018/01/18
Last modified on 2019/03/20

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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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