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

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 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


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

Value
https://center6.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