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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024881
Receipt No. R000028550
Scientific Title Case study for the purpose of problem extraction of the usual treatment for senile xerosis
Date of disclosure of the study information 2016/12/01
Last modified on 2018/04/17

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Basic information
Public title Case study for the purpose of problem extraction of the usual treatment for senile xerosis
Acronym Problem extraction of the usual treatment for senile xerosis
Scientific Title Case study for the purpose of problem extraction of the usual treatment for senile xerosis
Scientific Title:Acronym Problem extraction of the usual treatment for senile xerosis
Region
Japan

Condition
Condition senile xerosis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By evaluation of the biophysical skin changes in patients with senile xerosis treated with emollient and topical steroid, we aim to elucidate pathophysiology of senile xerosis and skin changes induced by the treatments.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes epidermal thickness at 2 or 3 months after the start of the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 External treatment of emollient and topical corticosteroid for 2 months or 3 months
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed as senile xerosis
Key exclusion criteria Past history of contact dermatitis to existing topical medication
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Hospital
Division name Dermatology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7271
Email kkikuchi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Hospital
Division name Dermatology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7271
Homepage URL
Email kkikuchi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Pola Pharma
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
2016 Year 12 Month 01 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 Completed
Date of protocol fixation
2016 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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 11 Month 17 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028550

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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