Koo, John, Koo, John, Tyring, Stephen, Werschler, William P, Bruce, Suzanne, Olesen, Martin, Villumsen, John, Bagel, Jerry, Koo, John, Koo, John, Tyring, Stephen, Werschler, William P, Bruce, Suzanne, Olesen, Martin, Villumsen, John, and Bagel, Jerry
BackgroundAn aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.ObjectivesTo compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.MethodsIn this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity.ResultsIn total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch).ConclusionsCal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.