The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
504
Service de Dermatologie, Hôspital Larrey
Toulouse, France
Treatment Success According to the PGA
To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Time frame: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel
Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.
Time frame: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel
Time to 'Treatment Success' According to PGA.
Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Time frame: From Baseline to Week 12
Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Time frame: Baseline to Week 4
Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
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Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Time frame: Baseline to Week 4; Baseline to Week 8