UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029756 |
|---|---|
| Receipt number | 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 14:15:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takashima@inforward.co.jp
Sponsor or person
Institute
Inforward, inc
EBISU skin research center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
