JPRN-UMIN000020325Completed未知
A study to determine the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in patients with severe psoriasis vulgaris - A study on the incidence of hypercalcemia with calcipotriol hydrate/betamethasone dipropionate ester fixed dose combination product in severe psoriasis vulgaris patients
Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences0 sites25 target enrollmentStarted: December 24, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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
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