UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000029583
Receipt number	R000033796
Scientific Title	Efficacy test for evaluating the effect of "composition A" on the skin redness.
Date of disclosure of the study information	2017/10/18
Last modified on	2018/10/17 11:36:06

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Basic information

Public title

Efficacy test for evaluating the effect of "composition A" on the skin redness.

Acronym

Efficacy test of "composition A" to the skin.

Scientific Title

Efficacy test for evaluating the effect of "composition A" on the skin redness.

Scientific Title:Acronym

Efficacy test of "composition A" to the skin.

Region

Japan

Condition

Healthy people

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To confirm effect and mechanism of influence on skin redness by "composition A".

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Skin redness induced by ammonia aqueous solution after 3 days third times consecutive 3 hours application (total 9 hours application in a day) of "composition A" and "placebo"

Key secondary outcomes

Stratum corneum components related with skin redness induced by ammonia aqueous solution after 3 days application (third times consecutive 3 hours application, total 9 hours application in a day) of "composition A" and "placebo"

Skin redness induced by ammonia aqueous solution after 3 hours application of "composition A", "placebo" and "composition B".

Amount of "composition A" and "composition B" transferred to skin after 3 hours application of "composition A", "placebo" and "composition B".

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Conduct evaluation 1) to 3) with 2 weeks interval.
1)Wash forearm -> 3 hours application of 3 different concentration of "composition A" and "placebo" -> evaluation of skin redness induced by ammonia aqueous solution.
2)Wash forearm -> 3 hours,3 times,3 days application of 4 different concentration of "composition A" and "placebo". -> evaluation of skin redness induced by ammonia aqueous solution and tape-stripping of stratum corneum.
3)Wash forearm -> 3 hours application of 4 different concentration of "composition A" -> tape-stripping of stratum corneum.

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

49 years-old >=

Gender

Male

Key inclusion criteria

1) 20-49 years old healthy man
2) Men who have healthy and non-troubled skin on their forearm

Key exclusion criteria

-Man who have dermatitis (atopic dermatitis etc.).
-Man under-medication.
-Man who have experience of skin troubled with products containing ammonium aqueous solution.
-Man who is judged as "not eligible" by investigator. For example, man who have sunburned skin, man who have pigmentation, man who have hairy skin, man who have significant skin contour by his mascule and blood vessel.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Junko Ishikawa

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

Address

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

TEL

+81-285-68-7473

Email

ishikawa.junko1@kao.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Maeko Iwamura

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

Address

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

TEL

+81-285-68-7443

Homepage URL

Email

iwamura.maeko@kao.co.jp

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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（栃木県）

Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 18 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 09 Month 28 Day

Date of IRB

Anticipated trial start date

2017 Year 10 Month 18 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

2017 Year 10 Month 16 Day

Last modified on

2018 Year 10 Month 17 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033796

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name