UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030829 |
|---|---|
| Receipt number | 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 08:45:38 |
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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
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
takashima@inforward.co.jp
Sponsor or person
Institute
INFORWARD inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035147
