Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.
The primary response criterion is the number of patients with controlled disease at week 8.
Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris|
- Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.
- The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
- Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
- Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||May 2006|
|The Guenther Dermatology Research Centre|
|London, Ontario, Canada, N6A3H7|
|Leipzig, Germany, 04103|
|Waterford Regional Hospital|
|Vällingby, Sweden, 16268|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Principal Investigator:||Colin Fleming, MD||Ninewells Hospital and Medical School, Ninewells, Dundee, UK|