UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026712
Receipt number R000030661
Scientific Title Use test of moisturizing agents for the patients with dry skin
Date of disclosure of the study information 2017/03/27
Last modified on 2019/04/22 16:15:18

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Basic information

Public title

Use test of moisturizing agents for the patients with dry skin

Acronym

Use test of moisturizing agents

Scientific Title

Use test of moisturizing agents for the patients with dry skin

Scientific Title:Acronym

Use test of moisturizing agents

Region

Japan


Condition

Condition

dry skin

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the efficacy of the moisturizing agents for the patients with dry skin such as atopic dermatitis or psoriasis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

survey slip about the QOL

Key secondary outcomes



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

use of the moisturizing agents (nov origo marine)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who has dry skin.

Key exclusion criteria

The patients who has allergy to the same moisturizing agents, who can not come again, and who is pregnant.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironobu Ihn

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo, Chou-ku, Kumamoto, 860-8556, Japan

TEL

096-373-5233

Email

satoshi.fukushima.tb@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Fukushima

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo, Chou-ku, Kumamoto, 860-8556, Japan

TEL

096-373-5233

Homepage URL


Email

satoshi.fukushima.tb@gmail.com


Sponsor or person

Institute

Kumamoto university

Institute

Department

Personal name



Funding Source

Organization

TOKIWA Pharmaceutical 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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 27 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

2016 Year 09 Month 30 Day

Date of IRB

2017 Year 02 Month 16 Day

Anticipated trial start date

2017 Year 03 Month 15 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 26 Day

Last modified on

2019 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name