Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris

LEO Pharma

Status and phase

Completed

Phase 4

Conditions

Psoriasis Vulgaris

Treatments

Drug: Calcipotriol plus betamethasone dipropionate ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00248456

EX 0501 CN

Details and patient eligibility

About

This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of psoriasis vulgaris in a stable condition
Extent of at least 10% of one or more body regions
Amenable to topical therapy with maximum of 100 g/week of investigational product

Exclusion criteria

Patients with more than 30% of body surface area involved
Patients with facial psoriasis who need treatment
Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives
Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis
Systemic treatment of psoriasis with corticosteroids or other therapy
Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period
Patients with planned exposure to phototherapy that may affect the psoriasis during the study period