UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of topical moisturizer in the treatment of skin xerosis in hemodilyzed patients
Title of the study (Brief title)	Usefulness of topical moisturizer in the treatment of skin xerosis in hemodilyzed patients
Region	Japan

Condition
Condition	Skin xerosis in hemodialyzed patient
Classification by specialty	Nephrology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of the skin care with topical moisturizer in the treatment of skin xerosis in hemodialyzed patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The water content of the stratum corneum
Key secondary outcomes	Efficacy (Skin xerosis, pruritus, etc. ), Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Base treatment
Interventions/Control_2	Base treatment + moisturizer
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Chronic renal failure patients who regularly receive hemodialysis two or three times a week and are not likely to have a serious treatment change or acute symptoms during the study period. (2) Patients with skin xerosis (3) Patients with pruritus at time of signing the consent form (4) Patients who signed informed consent. (5) Patients aged 20 to 80 years at time of signing the consent form. (6) Patients of either sex.
Key exclusion criteria	(1) Patients who received heparinoid- or urea -containing drugs within two weeks before signing the consent form. (2) Patients with/ with the past of extensive complications of the skin (burn, psoriasis etc.). (3) Patients with allergy to heparinoid. (4) Patients with hemorrhagic blood disease (hemophilia, thrombocytopenia, purpura etc.). (5) Patients who are expected a few bleeding causes a serious result. (6) Patients who participated in other clinical study within 4 months before starting study. (7) Patients who are unsuitable to the study at the investigator's discretion.
Target sample size	12

Research contact person
Name of lead principal investigator	Kazumasa Hashimoto
Organization	Nippon Medical School
Division name	The Kidney Disease Clinic of NMS
Address	Asaka Building, 1-7-15 Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL	03-3821-1601
Email	k-hashi@nms.ac.jp

Public contact
Name of contact person	Kazumasa Hashimoto
Organization	Nippon Medical School
Division name	The Kidney Disease Clinic of NMS
Address	Asaka Building, 1-7-15 Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL	03-3821-1601
Homepage URL
Email	k-hashi@nms.ac.jp

Sponsor
Institute	The Kidney Disease Clinic of Nippon Medical School
Institute
Department

Funding Source
Organization	Maruho Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	日本医科大学　腎クリニック　（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 19 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2016 Year 01 Month 31 Day
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	2015 Year 04 Month 02 Day
Last modified on	2016 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019734