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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024964
Receipt No. R000028724
Scientific Title iniks safety tests on Cleansing foam with atopic dermatitis
Date of disclosure of the study information 2016/11/25
Last modified on 2016/12/19

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Basic information
Public title iniks safety tests on
Cleansing foam with atopic dermatitis
Acronym Safety tests on Facial wash with Atopic Dermatitis patients
Scientific Title iniks safety tests on
Cleansing foam with atopic dermatitis
Scientific Title:Acronym Safety tests on Facial wash with Atopic Dermatitis patients
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The safety when using continuously for 4 weeks, in an atopic dermatitis patient is confirmed about iniks Cleansing foam
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questioning by a doctor and skin observation
Key secondary outcomes Questionnaire survey
Picture evaluation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Repeated use of a single-agent of Cleansing foam for 4 weeks
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
59 years-old >=
Gender Female
Key inclusion criteria The severity of the rash from minor moderate atopic dermatitis patients

And their written consent to participate in testing indicates the intention to participate to the test, and begin to understand the

A healthy 59 -year-old Japanese women from age 20 do not violate the exclusion criteria

Consent form, questionnaire and use journal papers are available by

Who can come to the testing facility observation date
Key exclusion criteria And who have so far caused allergic reactions in cosmetics

And severe hay fever

And those with a history of severe liver failure, renal failure, myocardial infarction

Pregnant or who might have become pregnant, and lactating

And who are participating in other clinical trials

Person who judged and other inappropriate exam by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maiko Tajima
Organization Beauty & Health Research_Inc
Division name MedicalResearch Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Email info@b-hr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nishimaki
Organization Beauty & Health Research_Inc
Division name Sales Depaetment
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Homepage URL
Email nishimaki@b-hr.jp

Sponsor
Institute Beauty & Health Research_Inc
Sales Depaetment
Institute
Department

Funding Source
Organization Maruho Co.,Ltd
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 株式会社ビューティアンドヘルスリサーチ(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 25 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
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 23 Day
Last modified on
2016 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028724

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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