Severe psoriasis vulgaris
Conditions
Interventions
Appropriate amount of study drug should be applied once daily to whole area affected by skin rash of psoriasis vulgaris. (for patients with skin rash over >
=20% of body surface area [BSA], the appropriate amount of Dovobet ointment to be applied is >
=5 g per day, not exceeding 90 g per week)
Sponsors
Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with plaque-type psoriasis vulgaris who have skin rash on the starting day of the study treatment, with 20%<=BSA<=30%. 2) Patients with age >=18 years at the time of obtaining written consent. However, if the patient is younger than 20 years of age, obtaining written consent from a delegate is required. 3) Gender - Not applicable 4) Inpatient/outpatient - Not applicable
Exclusion criteria
Exclusion criteria: 1. Serious allergy 2. Hypersensitivity to any ingredients in the study drug 3. Patients with skin infection due to bacteria, fungi, spirochetes, or viruses, or with an animal skin infection 4. Patients with ulcer, and frostbite/heat burn 5. Severe hepatic / renal / cardiac / pulmonary or other disorder which requires hospitalization 6. Skin disease concurrent with skin rash of psoriasis vulgaris 7. Patients who have been administered biologics, or retinoids within 3 months from the starting day of the study treatment 8. Patients who have received the following treatment within 4 weeks from the starting day of the study treatment 1) Phototherapy for skin rash of psoriasis vulgaris 2) The following systemic drugs: a) Vitamin D derivatives b) Drugs which may affect calcium metabolism c) Drugs which may affect the immune system d) Tar products e) Other drugs which have an indication of psoriasis 9. Patients who have taken the following therapeutic drugs or food within 2 weeks from the starting day of the study treatment 1) Topical vitamin D derivatives or supplements which contain vitamin D 2) The following topical drugs for skin rash of psoriasis vulgaris: 10. Patients whose laboratory test data collected before the starting day of the study treatment meets any of the criteria listed below a) Serum calcium and serum creatinine level >upper limit of the normal range b) AST and ALT level >=3 multiplied by upper limit of the normal range 11. Pregnant women, breastfeeding women, women who plan to get pregnant during the study period 12. Other patients whom the investigator or the subinvestigator have judged to be non-eligible as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum calcium level changes | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation -Adverse events (subjective symptoms, objective symptoms, abnormal changes in physical examination data, and laboratory test data) -Laboratory test data and physical examination data changes over time Efficacy evaluation -m-PASI over time | — |
Countries
Japan
Contacts
Public ContactSayumi Hasegawa
QOL RD Co.,Ltd. CRO Department Drug Division
Outcome results
None listed