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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023946
Receipt No. R000026390
Scientific Title Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Date of disclosure of the study information 2016/09/06
Last modified on 2017/11/17

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Basic information
Public title Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Acronym Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Scientific Title Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Scientific Title:Acronym Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Region
Japan

Condition
Condition psoriasis vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The current status investigation of symptoms of plaque psoriasis and their external treatment was conducted and reported by the Topical-therapy Survey Study Group for Psoriasis (TSGP). After 1 year, a follow-up survey was carried out in patients registered for this investigation to obtain evidence concerning the state of treatment and changes in patient satisfaction.
Basic objectives2 Others
Basic objectives -Others Actual condition survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Treatments for psoriasis vulgaris.
Satisfaction with treatment.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who were registered in the TSGP investigation between November 2014 and May 2015, and visited the hospital 4 or more times after the 3-month follow-up
2.Patients who fulfill the criterion 1) in March-June 2016 (as of March 2016, have visited the hospital regularly after the 3-month follow-up and are expected to visit 4 or more times by the end of June)
3.Patients who have used dovobet for more than 1 year
4.Patients who are aged 20 years and have given consent
Key exclusion criteria 1.Patients who are or may be pregnant and those who are breast-feeding
2.Patients judged to be inappropriate as a subject of this study by the investigator physician
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Nemoto
Organization Sapporo dermatology Clinic
Division name Director
Zip code
Address 5th Floor, H&B Plaza Building, 2-1-1 Minami Sanjo Nishi, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-221-8807
Email sapporo@kojinkai.org

Public contact
Name of contact person
1st name
Middle name
Last name Sayumi Hasegawa
Organization QOL RD Co.,Ltd.
Division name Clinical Research Department CRO Division
Zip code
Address Front Place Nihonbashi Bldg. 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL 03-6386-8800
Homepage URL
Email tsgp-study@qol-rd.co.jp

Sponsor
Institute Topical-therapy Survey Study Group for Psoriasis
Institute
Department

Funding Source
Organization LEO Pharma K.K.
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 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

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 03 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Treatment strategies for psoriasis vulgaris.
Satisfaction with treatment.

Management information
Registered date
2016 Year 09 Month 06 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026390

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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