UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023946 |
|---|---|
| Receipt number | 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 12:29:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tsgp-study@qol-rd.co.jp
Sponsor or person
Institute
Topical-therapy Survey Study Group for Psoriasis
Institute
Department
Personal name
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
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
Value
https://center6.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 |
