UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effective comparative study of moisture cream for itching in the senile dry skin
Title of the study (Brief title)	The influence of moisture cream for itching by dry skin
Region	Japan

Condition
Condition	asteatotic eczema
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of moisture cream for itching by dry skin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of the skin severity index on 4 weeks after study starting
Key secondary outcomes	Investigating of VAS for itching,water content in the corneal layer,TEWL,the nerve perception for the skin stimulation, analysis of the corneal layer by ELISA and immunostaining on 4 weeks after study starting

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	Medicine
Interventions/Control_1	Patients apply medical white vaseline and cosmetics cream to the leg of right and left twice a day each at random for four 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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The man and woman who has a dry symptom of the skin with itching including dermatitis to a leg 60 years or older
Key exclusion criteria	The person who produced the exacerbation of a contact dermatitis and the itch by the ingredient included in this study product in the past
Target sample size	30

Research contact person
Name of lead principal investigator	Ichiro Katayama
Organization	Osaka University Graduate School of Medicine
Division name	Department of Dermatology
Address	2-2 yamadaoka Suita city, Osaka
TEL	06-68779-3031
Email	katayama@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	Saori ochi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Dermatology
Address	2-2 yamadaoka Suita city, Osaka
TEL	06-6879-3031
Homepage URL
Email	102itoi@derma.med.osaka-u.ac.jp

Sponsor
Institute	Department of Dermatology, Osaka University Graduate School of Medicine
Institute
Department

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)

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 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029148