Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study

Abstract

Background: An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.

Objectives: To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.

Methods: In 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.

Results: In 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).

Conclusions: Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.

Keywords: Aerosol foam; betamethasone dipropionate; calcipotriene; psoriasis vulgaris; topical treatments.

Figure 1.

Study design. Calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD); FU, follow up; SV, screening visit.

Figure 2.

CONSORT diagram. *Patient did not administer any study treatment. ^†Other reasons included: one was unable to complete weeks 1 and 2 and one missed week 1. ‡Withdrawal of consent to start methotrexate again. BD, betamethasone dipropionate 0.064%; Cal, calcipotriene 0.005%; ITT, intention to treat.

Figure 3.

Proportion of patients achieving PGA-assessed treatment success* over time. *Investigator assessment by PGA as “clear” or “almost clear” with at least a two-step improvement was defined as patient having achieved treatment success. Bars show 95% confidence interval. BD, betamethasone dipropionate 0.064%; Cal, calcipotriene 0.005%.

Figure 4.

Change in mean mPASI over time. Bars show 95% confidence interval. BD, betamethasone dipropionate 0.064%; Cal, calcipotriene 0.005%; mPASI, modified psoriasis area severity index.

Figure 5.

Mean itch (by visual analogue scale) over time. BD, betamethasone dipropionate 0.064%; Cal, calcipotriene 0.005%; VAS, visual analogue scale.