UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016257 |
|---|---|
| Receipt number | R000018841 |
| Scientific Title | Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis |
| Date of disclosure of the study information | 2015/01/19 |
| Last modified on | 2017/01/06 11:17:36 |
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Basic information
Public title
Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Acronym
Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Scientific Title
Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Scientific Title:Acronym
Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Region
| Japan |
Condition
Condition
psoriasis vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to understand how the availability of a new topical compound consisting of active vitamin D3 and steroid affects treatment and patient satisfaction in clinical practice.
Basic objectives2
Others
Basic objectives -Others
Actual condition survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Treatment strategies for plaque psoriasis
- 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
- Patients aged 20 years or older who are diagnosed with plaque psoriasis
- Patients who are scheduled to start at least 4 weeks of treatment with a topical compound consisting of active vitamin D3 and steroid or who are currently treated with the compound
Key exclusion criteria
- Patients without plaque psoriasis
- Patients under the age of 20 years
- Patients who are not scheduled to be treated with a topical compound consisting of active vitamin D3 and steroid
Target sample size
1000
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 | Eri Muto |
Organization
QOL RD Co.,Ltd.
Division name
Clinical Development Group 1 CRO Department Drug Division
Zip code
Address
Front Place Nihonbashi Bldg. 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
03-6386-8801
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
| 2015 | Year | 01 | Month | 19 | 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
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
| 2014 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
- Treatment strategies for plaque psoriasis
- Satisfaction with treatment
Management information
Registered date
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018841
