UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	iniks Cleansing foam various safety test in the patients with Acne Vulgaris
Title of the study (Brief title)	Safety tests on Facial wash with 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 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 Acne Vulgaris patient who has Inflammatory skin rash (red papula, pustula) of 1-20 acne in a piece face 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	Maiko Tajima
Organization	Beauty & Health Research_Inc
Division name	MedicalResearch Department
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	Yuji Nishimaki
Organization	Beauty & Health Research_Inc
Division name	Sales Depaetment
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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 13 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000028725