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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031798 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Plaque Psoriasis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kojinkai, Association of Medical Corporation
Research Institute of Psoriasis Hosui General Medical Clinic |
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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 |
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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 | |
Institute | Kojinkai, Association of Medical Corporation |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036112 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |