UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031798 |
|---|---|
| Receipt number | R000036112 |
| Scientific Title | A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis. |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2018/12/26 16:20:24 |
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Basic information
Public title
A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Acronym
A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Scientific Title
A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Scientific Title:Acronym
A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Region
| Japan |
Condition
Condition
Plaque Psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine efficacy, safety and patient's satisfaction of maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mPASI (modified Psoriasis Area and Severity Index) score and improvement rate
Key secondary outcomes
Total PSI (Psoriasis Severity Index) score and improvement rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical combined containing vitamin D3 and corticosteroid
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Clinical diagnosis of plaque psoriasis amenable to topical treatment for psoriasis lesion except for head, face and neck.
(2)A target lesion of scoring at least 3 for each of redness, thickness and scale, and at least 10 in total
(3)Patients who have 3 - 10% body surface area (BSA)
(4)16 years of age or above
(5)Patients who signed informed consent after receiving sufficient explanation and agreement of participation of this study
(6)If the patient is of minors, written informed consent by the legal guardian should be obtained.
Key exclusion criteria
(1)Serious drug hypersensitivity or history of allergic reaction against maxacalcitol or betamethasone butyrate propionate
(2)Patients who have skin disease with bacterium, fungus, spirochaete, virus or skin disease with animal
(3)Patients who have ulceration, burn, cold injury
(4)Patients who have hypercalcemia
(5)Patients who have renal function deterioration
(6)Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding
(7)Patients who participated in other clinical study within 4 months prior to starting this study
(8)Patients who received topical treatment of psoriasis lesion except for head, face and neck within 14 days before starting this study
(9)1)Ultraviolet therapy within 28 days before starting this study.
2)Systemic treatments (e.g., vitamin D analogues, retinoids, ciclosporin, apremilast) within 28 days before starting this study.
(10)Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to starting this study:
1)secukinumab:150 days
2)ustekinumab:120 days
3)infliximab, adalimumab, ixekizumab, brodalumab:90 days
4)other products -90 days/5 half-lives (whichever is longer).
(11)Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs and lithium) during the study.
(12)Those who the investigator or sub-investigator judges are ineligible
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Iizuka |
Organization
Kojinkai, Association of Medical Corporation
Research Institute of Psoriasis
Hosui General Medical Clinic
Division name
Dermatology
Zip code
Address
1-4,Nishi2-chome,minami7-jo,Chuo-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-520-2310
iizuka_hajime_chiken@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Tsubouchi |
Organization
Linical Co., Ltd.
Division name
Contract Medical Affairs, Clinical Trial Division
Zip code
Address
1-6-1, Miyahara, Yodogawa-ku,
TEL
06-6150-2332
Homepage URL
tsubouchi-ryoichi@linical.co.jp
Sponsor or person
Institute
Kojinkai, Association of Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd.
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
| 2018 | Year | 03 | Month | 28 | 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
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036112
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