UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031577 |
|---|---|
| Receipt number | 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 11:27:20 |
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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
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
ishii@b-hr.jp
Sponsor or person
Institute
Beauty & Health Research_Inc
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036054
