UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005814 |
|---|---|
| Receipt number | R000006877 |
| Scientific Title | Clinical trial for efficacy of proactive sequential therapy using topical active Vitamin D and corticosteroids on psoriatic vulgaris |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2015/12/21 23:53:37 |
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Basic information
Public title
Clinical trial for efficacy of proactive sequential therapy using topical active Vitamin D and corticosteroids on psoriatic vulgaris
Acronym
Efficacy of proactive sequential therapy on psoriatic vulgaris
Scientific Title
Clinical trial for efficacy of proactive sequential therapy using topical active Vitamin D and corticosteroids on psoriatic vulgaris
Scientific Title:Acronym
Efficacy of proactive sequential therapy on psoriatic vulgaris
Region
| Japan |
Condition
Condition
psoriatic vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a clinical trial for efficacy of proactive sequential therapy using topical active Vitamin D and corticosteroids on psoriatic vulgaris
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psoriasis area and severity index (PASI) score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Exam.1. Topically apply Antebate ointment once a day for 2 weeks.
Interventions/Control_2
Exam. 2. Patients who reach PASI 50 (more than 50% improvement of PASI score) in exam. 1 are divided into two groups by random allocation based on initial PASI; Group A receive Antebate ointment reactive to aggravation of skin symptoms and group B receive Antebate ointment twice weekly. Both groups receive daily Dovonex ointment in addition to the treatment using Antebate ointment mentioned above.
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
Inclusion: Moderately to severely affected patients with psoriasis vulgaris who are 20 years old or above.
Key exclusion criteria
1. Patients who receive oral cyclosporine, methotrexate and corticosteroids, ultraviolet therapy or any biologics.
2. Patients who are allergic to either Antebate- or Dovonex ointment.
3. Patients who are pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masutaka FURUE |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Dermatology
Zip code
Address
Maidashi 3-1-1, Higasi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5585
nakahara@dermatol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi NAKAHARA |
Organization
Kyushu University Hospital
Division name
Department of Dermatology
Zip code
Address
Maidashi 3-1-1, Higasi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5585
Homepage URL
http://www.kyudai-derm.org/part/treat/recent.html
nakahara@dermatol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Graduate School of Medical Sciences, Kyushu University.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006877
| 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 |
