Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris

Abstract

Background and objective: The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 μg/g (as hydrate; Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment.

Methods: This was a Phase IIa, single-centre, investigator-blinded, exploratory study, with intra-individual comparison using a modified psoriasis plaque test. Patients were treated once daily (6 days/week) for 4 weeks with Cal/BD foam, Cal/BD ointment, BD foam and Cal/BD foam vehicle, randomized to four plaque test sites (5 cm(2) each). The primary efficacy endpoint was change in total clinical score (TCS; sum of erythema, scaling and lesional thickness). Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor band thickness, and adverse events.

Results: Twenty-four patients, median age 52.5 years (range 21-75), completed this study. At week 4, test sites treated with Cal/BD foam had a significantly greater decrease in mean (±SD) TCS (-6.00 ± 1.27) versus those treated with Cal/BD ointment (-5.25 ± 1.78; difference -0.75; 95 % CI -1.46 to -0.04; p = 0.038), BD foam (-4.96 ± 1.85; difference -1.04; 95 % CI -1.75 to -0.33; p = 0.005) or foam vehicle (-1.88 ± 1.12; difference -4.13; 95 % CI -4.83 to -3.42; p < 0.001). Total skin thickness and echo-poor band thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators. Eleven patients reported 17 adverse events, the most frequent being headache (five patients). There were no lesional/perilesional adverse events or adverse drug-related events.

Conclusions: Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.

Trial registration: ClinicalTrials.gov NCT01347255.

Fig. 1

Change from baseline (mean ± standard deviation) in a TCS, and its components b erythema, c scaling, and d lesional thickness, to end of treatment. BD betamethasone 0.5 mg/g (as dipropionate), Cal calcipotriol 50 µg/g (as hydrate), TCS total clinical score

Fig. 2

Change from baseline (mean ± standard deviation) in total skin thickness (assessed by ultrasonographic imagery) to end of treatment. BD betamethasone 0.5 mg/g (as dipropionate), Cal calcipotriol 50 µg/g (as hydrate)

Fig. 3

Change from baseline (mean ± standard deviation) in echo-poor band thickness (assessed by ultrasonography) to end of treatment. BD betamethasone 0.5 mg/g (as dipropionate), Cal calcipotriol 50 µg/g (as hydrate)