UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019048
Receipt number R000022026
Scientific Title Influence of the formulationC4W on epidermis.
Date of disclosure of the study information 2015/09/17
Last modified on 2016/03/10 16:17:57

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Basic information

Public title

Influence of the formulationC4W on epidermis.

Acronym

Influence of the formulationC4W on epidermis.

Scientific Title

Influence of the formulationC4W on epidermis.

Scientific Title:Acronym

Influence of the formulationC4W on epidermis.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the changes of physiological properties of the skin in healthy subjects by application of active ingredient.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Change of water content in stratum corneum after the topical application for 4 weeks
-Change of NMF content in stratum corneum after the topical application for 4 weeks

Key secondary outcomes

-Change of epidermal thickness
-Morphological change of epidermal cells
-Change of the properties of fluorescence from epidermis
-Change of the blood flow in skin
-Change of the melanin content in epidermis


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

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the formulation including an active ingredient and placebo to both forearm skin respectively twice daily 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

Male

Key inclusion criteria

Healthy male

Key exclusion criteria

-Subjects with cutaneous symptoms of atopic dermatitis
-Subjects regularly going to hospital for sickness
-Subjects undergoing hormone therapy
- Subjects who are taking OCT or prescription medicine
-Subjects with clinically-significant disorder (eczema, a scratch etc.) at the sites to be studied
-Subjects participation in another clinical study accompanied by topical application of formulations and tape stripping or delipidation treatment to obtain experimental dry skin to the sites to be studied within the past 1 month.
-Subjects take carbon dioxide bath or carbonated spring within the past 1 month.
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Murase

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

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

TEL

0285-68-7871

Email

murase.takatoshi@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiichi Sugata

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

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

TEL

0285-68-7872

Homepage URL


Email

sugata.keiichi@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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

花王株式会社栃木事業場生理機能棟(栃木)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 17 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

2015 Year 09 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 03 Month 10 Day

Date analysis concluded

2016 Year 03 Month 10 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 17 Day

Last modified on

2016 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022026


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name