UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037467
Receipt number R000042714
Scientific Title A Study on the skin change by continuous use of carbonated cosmetics
Date of disclosure of the study information 2019/09/10
Last modified on 2019/07/24 14:14:46

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Basic information

Public title

A Study on the skin change by continuous use of carbonated cosmetics

Acronym

A Study on the skin change by continuous use of carbonated cosmetics

Scientific Title

A Study on the skin change by continuous use of carbonated cosmetics

Scientific Title:Acronym

A Study on the skin change by continuous use of carbonated cosmetics

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy and safety of of the test products for healthy male and female facial skin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the dermatological assessment by doctor after 2 and 4 weeks of continuous use of test products

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Use the test product every twice a day for 4 weeks

Interventions/Control_2

Use the placebo every twice a day for 4 weeks

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

39 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy male and females

Key exclusion criteria

-Subjects with atopic dermatitis and pollen allergy
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masaru
Middle name
Last name Hosokawa

Organization

Kao Corporation

Division name

Skin Care Research

Zip code

131-8501

Address

2-1-3 Bunka,Sumida-ku Tokyo 131-8501, JAPAN

TEL

+81-3-5630-7286

Email

hosokawa.masaru@kao.com


Public contact

Name of contact person

1st name Aiko
Middle name
Last name Kiyozuka

Organization

Kao Corporation

Division name

Skin Care Research

Zip code

131-8501

Address

2-1-3 Bunka,Sumida-ku Tokyo 131-8501, JAPAN

TEL

+81-3-5630-7287

Homepage URL


Email

kiyozuka.aiko@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.com


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

DRC株式会社(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 10 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

Preinitiation

Date of protocol fixation

2019 Year 08 Month 21 Day

Date of IRB

2019 Year 08 Month 30 Day

Anticipated trial start date

2019 Year 09 Month 23 Day

Last follow-up date

2019 Year 11 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 24 Day

Last modified on

2019 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name