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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029756
Receipt No. R000033996
Scientific Title A using test for four continuous weeks of skin care product against male atopic dermatitis patients
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/13

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Basic information
Public title A using test for four continuous weeks of skin care product against male atopic dermatitis patients
Acronym A using test for four continuous weeks of skin care product against male atopic dermatitis patients
Scientific Title A using test for four continuous weeks of skin care product against male atopic dermatitis patients
Scientific Title:Acronym A using test for four continuous weeks of skin care product against male atopic dermatitis patients
Region
Japan

Condition
Condition Minor to mild whole face atopic dermatitis, according to the severity classification of rash in the atopic dermatitis guideline of Japanese Dermatological Association.
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and usefulness of new developed male cosmetic on four continuous weeks using in atopic dermatitis patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Doctor's findings such as dryness or scales, erythema, papules, scratch marks on the face.
Key secondary outcomes Stratum corneum water content, transepidermal water transpiration amount, microscope photography, photography, questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Inspection such as observation, measurement and questionnaire before test start - Apply the test sample on whole face, two times in a day, in the morning and the evening, for two weeks - Inspection such as observation, measurement and questionnaire, at two weeks after test start - Apply the test sample on whole face, two times in a day, in the morning and the evening, for two weeks - Inspection such as observation, measurement and questionnaire, at four weeks after test start
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
49 years-old >=
Gender Male
Key inclusion criteria Those who satisfy all of the following conditions
1) Male aged 20 to 49.
2) Subjects who have minor to mild whole face atopic dermatitis, according to the severity classification of rash in the atopic dermatitis guideline of Japanese Dermatological Association.
3) Subjects who are using skin care product, such as facial wash, more than once in a day on their face in currently.
4) Subjects who show their willingness of participating to the test, and who obtain consent to participate in the test after understanding explanation of test.
Key exclusion criteria 1) Subjects who have skin symptom such as moderate or higher atopic dermatitis, oral dermatitis, rosacea-like dermatitis.
2) Subjects who have trauma on the site of observation.
3) Subjects who have possibility to take a lot of sunlight such as daily sports at outside.
4) Subjects who have allergic symptoms against external medicine, cosmetic, quasi-drugs and others in the past.
5) Subjects who have severe hay fever.
6) Heavy alcohol drinker.
7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, myocardial infarction.
8) Subjects who have severe anemia.
9) Subject who are going to hospital and being accepted medical treatment due to disease, except dentistry.
10) Persons who concern this test such as requester of this test and employee of trustee company.
11) Subjects who themselves and/or their family are working for a pharmaceutical companies and cosmetic companies.
12) Subjects who are participating in clinical tests, use tests and product monitor tests of medicines etc. And subjects who have been participated within 3 month in those tests described above.
13) Others who have been determined ineligible by investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Yamaguchi
Organization DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name R&D Department
Zip code
Address 3-14-10 Nihonbashi Chuo-ku, Tokyo 103-8234, JAPAN
TEL 03-5255-6336
Email yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

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 Ebisu Shibuya-ku, Tokyo 150-0013, JAPAN
TEL 03-5793-8712
Homepage URL
Email takashima@inforward.co.jp

Sponsor
Institute Inforward, inc
EBISU skin research center
Institute
Department

Funding Source
Organization DAIICHI SANKYO HEALTHCARE CO., LTD.
R&D Department
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 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 10 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 02 Day
Last follow-up date
2017 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 30 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033996

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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