UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevening effect of bath additives for dry skin and itch.
Title of the study (Brief title)	Prevening effect of bath additives for dry skin and itch.
Region	Japan

Condition
Condition	Xerosis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Preventing effect of bath additives for dry skin and itch.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin condition:dry skin, scale, erythema itch: VAS TEWL, SH, Sebum (first vist,4 weeks, 8 weeks)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Duration: 8 weeks soak in the bathtub with bath additives more than 4 times a week
Interventions/Control_2	Duration: 8 weeks soak in the bathtub without bath additives more than 4 times a week
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	45 years-old <=
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	1)have dry skin on the lumbar area or legs in autum and winter seasons. 2)soak in the bathtub more than 4 times a week 3)written informed consent
Key exclusion criteria	1)not apropriate to registration 2)have skin troubles except for dry skin 3)have medical treatment due to skin disease 4)put moisturizing cream on the entire body 5)soak in the bathtub less than 3 times a week
Target sample size	40

Research contact person
Name of lead principal investigator	Masako Minami-Hori
Organization	Asahikawa Medical University
Division name	Dermatology
Address	Midorigaoka-Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL	0166-68-2523
Email	masakoh@asahikawa-med.ac.jp

Public contact
Name of contact person	Masako Minami-Hori
Organization	Asahikawa Medical University
Division name	Dermatology
Address	Midorigaoka-Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL	0166-68-2523
Homepage URL
Email	masakoh@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Shiseido.Co
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	EXAM.Co
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	2016 Year 08 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 23 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 08 Month 15 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027215