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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025701
Receipt No. R000029567
Scientific Title Effect of topical application with Sakran on dry skin subjects
Date of disclosure of the study information 2017/01/17
Last modified on 2017/01/16

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Basic information
Public title Effect of topical application with Sakran on dry skin subjects
Acronym Effect of topical application with Sakran on dry skin subjects
Scientific Title Effect of topical application with Sakran on dry skin subjects
Scientific Title:Acronym Effect of topical application with Sakran on dry skin subjects
Region
Japan

Condition
Condition dry skin
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to improve treatment of sakuran to dry skin, we conduct treatment sakuran on the skin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Moisture of skin surface after treatment of sakran at 28 days
Key secondary outcomes we also measure skin surface oil, power of hydrogen and macroscopic observation of skin surface at same days.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sakuran was treated to right arm of elderly pepole, twice a day, at 14 adys and 28 days we measure moisture, oil and power of hydrogen on skin surface.
Interventions/Control_2 Vaseline was treated on left arm of elderly people as a control.
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
65 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dry skin subject
Key exclusion criteria subject has inflammatory on his skin
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name RYOJI HIROTA
Organization KOCHI MEDICAL SCHOOL
Division name Department of Environmental Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 0888802407
Email hirotar@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name RYOJI HIROTA
Organization KOCHI MEDICAL SCHOOL
Division name Department of Environmental Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 0888802407
Homepage URL
Email hirotar@kochi-u.ac.jp

Sponsor
Institute Department of Environmental Medicine,KOCHI MEDICAL SCHOOL
Institute
Department

Funding Source
Organization Dai to kasei,.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 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Topical application of sakuran was improved the dry skin, however, vasselin was better than sakuran.
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
2011 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 30 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 08 Month 31 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029567

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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