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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023631
Receipt No. R000027215
Scientific Title Prevening effect of bath additives for dry skin and itch.
Date of disclosure of the study information 2016/08/16
Last modified on 2016/08/15

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Basic information
Public title Prevening effect of bath additives for dry skin and itch.
Acronym Prevening effect of bath additives for dry skin and itch.
Scientific Title Prevening effect of bath additives for dry skin and itch.
Scientific Title:Acronym 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
1st name
Middle name
Last name Masako Minami-Hori
Organization Asahikawa Medical University
Division name Dermatology
Zip code
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
1st name
Middle name
Last name Masako Minami-Hori
Organization Asahikawa Medical University
Division name Dermatology
Zip code
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)

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
2016 Year 08 Month 16 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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