Plaque Psoriasis
Conditions
Interventions
Topical combined containing vitamin D3 and corticosteroid
Sponsors
Kojinkai, Association of Medical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPASI (modified Psoriasis Area and Severity Index) score and improvement rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Total PSI (Psoriasis Severity Index) score and improvement rate | — |
Countries
Japan
Contacts
Public ContactRyoichi Tsubouchi
Linical Co., Ltd. Contract Medical Affairs, Clinical Trial Division
Outcome results
None listed