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A study to evaluate the topical switching therapy from combined vitamin D3/corticosteroid to vitamin D3 alone in plaque psoriasis

A study to evaluate the topical switching therapy from combined vitamin D3/corticosteroid to vitamin D3 alone in plaque psoriasis - Topical switching therapy for plaque psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019379
Enrollment
30
Registered
2015-10-16
Start date
2015-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Interventions

Switching from topical combined vitamin D3/corticosteroid to topical vitamin D3 analogue

Sponsors

Kojinkai, Association of Medical Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Clinical diagnosis of plaque psoriasis amenable to topical treatment, involving arms and/or trunk and/or legs. (2)A target lesion of scoring at least 3 for each of redness, thickness and scale, and at least 10 in total (3)16 years of age or above

Exclusion criteria

Exclusion criteria: (1) History of allergic reaction against maxacalcitol, calcipotriol and betamethasone dipropionate (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) Topical treatment of psoriasis on the target lesion within 14 days prior to starting this study. (8) 1) Ultraviolet therapy on target lesion within 28 days prior to starting this study. 2) Systemic treatments (e.g., vitamin D analogues, retinoids, ciclosporin ) within 28 days prior to starting this study. (9) 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:90 days 4) other products - 3 months/5 half-lives (whichever is longer). (10) Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs and lithium) during the study. (11) Those who the investigator or sub-investigator judges are ineligible

Design outcomes

Primary

MeasureTime frame
Total PSI(Psoriasis Severity Index) score and improvement rate are evaluated at 0, 5, 10 and 14 weeks.

Countries

Japan

Contacts

Public ContactKatsumi Watanabe

Mebix, Inc Research Promotion Head Office

k-watanabe@mebix.co.jp03-6229-8936

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026