UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032546
Receipt number R000037120
Scientific Title A Study on the dermatological efficacy of KB extracts for dry skin
Date of disclosure of the study information 2018/05/15
Last modified on 2020/11/11 11:57:08

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Basic information

Public title

A Study on the dermatological efficacy of KB extracts for dry skin

Acronym

Efficacy test of KB extracts for skin

Scientific Title

A Study on the dermatological efficacy of KB extracts for dry skin

Scientific Title:Acronym

Efficacy test of KB extracts for skin

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the dermatological efficacy of KB extracts for healthy female skin

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the stinging test value after the application for 2 weeks with KB extract contain skin care products

Key secondary outcomes

Evaluation of the water content, the trans-epidermal water loss and the dermatological assessment after the application for 2 weeks with KB extract contain skin care products


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the K extract contain skin care product for face twice a day for 2 weeks

Interventions/Control_2

Apply the B extract contain skin care product for face twice a day for 2 weeks

Interventions/Control_3

Apply the placebo skin care product for face twice a day for 2 weeks

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

60 years-old >=

Gender

Female

Key inclusion criteria

Healthy females

Key exclusion criteria

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

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takafumi Nishijima

Organization

Kao Corporation

Division name

Safety Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7520

Email

nishijima.takafumi@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Rie Ninomiya

Organization

Kao Corporation

Division name

Safety Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7520

Homepage URL


Email

ninomiya.rie@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

Interface Ink.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

H30-022

Org. issuing International ID_1

Interface, Ink.

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

インターフェイス株式会社(秋田県)


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 15 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

2018 Year 04 Month 25 Day

Date of IRB

2018 Year 04 Month 25 Day

Anticipated trial start date

2018 Year 05 Month 15 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 10 Day

Last modified on

2020 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name