UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Follow-up survey 1 year after a current status investigation of external treatment for plaque psoriasis
Title of the study (Brief title)	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	Osamu Nemoto
Organization	Sapporo dermatology Clinic
Division name	Director
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	Sayumi Hasegawa
Organization	QOL RD Co.,Ltd.
Division name	Clinical Research Department CRO Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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