UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025083 |
|---|---|
| Receipt number | R000028848 |
| Scientific Title | A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2023/12/07 23:00:14 |
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Basic information
Public title
A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Acronym
A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Scientific Title
A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Scientific Title:Acronym
A study of long-term efficacy and safety of calcipqotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with psoriasis vulgaris
Region
| Japan |
Condition
Condition
psoriasis vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find evidence of efficacy and safety of long term use of Dovobet ointment on patients with psoriasis vulgaris
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
comparison of m-PASI score at week 0, week 4, week24, and week52.
Key secondary outcomes
PGA and safety
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) Age: 20 years old or over
2) Symptom: Manageable within 10g/day of Dovobet
3) Sex, inpatient/outpatient, does not matter
Key exclusion criteria
1) pregnant, or possibly pregnant women
2) subjects contraindicated by package insert
3) subjects judged unsuitable by physicians
4) subjects who are going to receive oral or injective steroid, cyclosporine, methotrexate, biologics, ultraviolet therapy, herbal medication against psoriasis within the trial period., 5) subjects who used Dovobet within 4 weeks before starting the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Imafuku |
Organization
Fukuoka University
Division name
Department of dermatology
Zip code
814-0180
Address
7-45-1, Nanakuma, Jonanku, Fukuoka city
TEL
092-801-1011
dermatologist@mac.com
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Imafuku |
Organization
Fukuoka University
Division name
Department of dermatology
Zip code
814-0180
Address
7-45-1, Nanakuma, Jonanku, Fukuoka city
TEL
092-801-1011
Homepage URL
dermatologist@mac.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Shinichi Imafuku
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Internal Review Board, Fukuoka University
Address
7-45-1, Nanakkuma, Jonan-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-801-1011
dermatol@fukuoka-u.ac.jp
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
| 2017 | Year | 05 | Month | 15 | 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
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of daily treated, or weekend treated, or calcipqotriol treated patients.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028848
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
