Psoriasis vulgaris of the trunk and/or limbs with at least 10% involvement of arms and/or 10% of legs and/or 10% of trunk MedDRA version: 7.0 Level: LLT Classification code 10050576
Conditions
Interventions
Trade Name: Dovobet
Pharmaceutical Form: Ointment
INN or Proposed INN: Calcipotriol
CAS Number: 147657-22-5
Concentration unit: mg/kg mi
Sponsors
LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S )
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of psoriasis vulgaris amenable to treatment with a maximum of 100g of topical medication per week, involving arms and/or trunk and/or legs. 2. An investigators’ global assessment of moderate, severe or very severe disease. 3. A minimum PASI score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms and/or 10% of trunk and/or 10% of legs). 4. Attending hospital outpatient clinic, the private practice of a dermatologist or general practice for psoriasis treatment. 5. Aged 18 years or above. 6. Either sex. 7. Any ethnic origin. 8. Following receipt of verbal and written information about the study, the patient must provide signed and dated informed consent before any trial related activity is carried out. 9. Females of child-bearing potential must have a negative result for a urine pregnancy test before randomisation and must agree to use an adequate method of contraception during the study. 10. Patients fulfilling national requirement/law for participation in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Requirement for treatment of more than 30% of body surface area with study medication. 2. Current diagnosis of erythrodermic, exfoliative, pustular or guttate psoriasis. 3. Use of systemic treatments which may have an effect on psoriasis (apart from biologic therapies) within 4 weeks prior to visit 1. Such treatments are corticosteroids, retinoids, hydroxycarbamide, azathioprine, methotrexate, ciclosporin and other immunosuppressants. 4. Use of biologic therapies which may have an effect on psoriasis within 6 months prior to visit 1. 5. PUVA or Grenz ray therapy within 4 weeks prior to visit 1. 6. UVB therapy within 2 weeks prior to visit 1. 7. Planned use of topical treatment for psoriasis of trunk or limbs besides study medication (including the use of emollient) during the study (no washout period before randomisation is necessary). 8. Planned initiation of or changes to non-antipsoriatic concomitant medication that could affect psoriasis (e.g. beta-blockers, lithium) during the study. 9. Planned exposure to sun during the study, that may affect the psoriasis. 10. Known or suspected hypersensitivity to any of the constituents of the study medications. 11. Known disorders of calcium metabolism associated with hypercalcaemia. 12. Patients with any of the following conditions also present on psoriatic areas of the trunk or limbs: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers or wounds. 13. Other inflammatory skin diseases that may confound the evaluation of the psoriasis. 14. Females who are pregnant, breast feeding or who wish to become pregnant during the study period. 15. Patients who have received treatment with an investigational product within 4 weeks prior to visit 1 or are currently participating in another clinical trial. 16. Previous enrolment into this study. 17. Patient known or suspected of being unable to comply with the study protocol for the 12-week period, e.g. due to alcoholism, drug dependence or psychotic state. 18. Severe renal insufficiency or severe hepatic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of the following treatment regimens: • 4 weeks of combination ointment followed by 8 weeks of calcipotriol cream [combination/calcipotriol (4/8)] • 4 weeks of combination ointment followed by 8 weeks of vehicle of calcipotriol cream [combination/vehicle (4/8)] in the treatment of patients with psoriasis. ; Secondary Objective: To compare the clinical efficacy of the following treatment regimens: • 4 weeks of combination ointment followed by 8 weeks of calcipotriol cream on weekdays (Monday to Friday)/combination ointment on weekends (Saturday and Sunday) [combination/calcipotriol weekdays, combination weekends (4/8)] • Combination/vehicle (4/8) in the treatment of patients with psoriasis vulgaris. To compare the safety of the combination/calcipotriol (4/8) group with that of the combination/vehicle (4/8) group, and of the combination/calcipotriol weekdays, combination weekends (4/8) group with that of the combination/vehicle (4/8) group in the treatment of patients with psoriasis vulgaris. ;Primary end point(s): Percentage change in PASI from baseline (visit 1) to end of trial. | — |
Countries
Belgium, Germany, Spain, United Kingdom
Outcome results
None listed