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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031577
Receipt No. R000036054
Scientific Title Safety test of facial cleansing agent in acne vulgaris patients
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/05

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Basic information
Public title Safety test of facial cleansing agent in acne vulgaris patients
Acronym Safety test of facial cleansing agent in acne vulgaris patients
Scientific Title Safety test of facial cleansing agent in acne vulgaris patients
Scientific Title:Acronym Safety test of facial cleansing agent in acne vulgaris patients
Region
Japan

Condition
Condition Acne vulgaris
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 Acne Vulgaris patient is confirmed about facial cleansing agents
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 4 weeks continuous use group of facial cleansing agent
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 Acne Vulgaris patient who has Inflammatory skin rash (red papula, pustula) of 1-20 acne in a piece face

Person who uses facial cleansing agent when making makeup more than six times a week and dropping makeup

Person who uses facial cleanser after facial cleansing agent

And their written consent to participatein 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 Tomiko Ishii
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
Homepage URL
Email ishii@b-hr.jp

Sponsor
Institute Beauty & Health Research_Inc
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
2018 Year 03 Month 05 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 26 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 22 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
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036054

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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