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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Atopic dermatitis | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |