Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris

Abstract

Background and ObjectiveThe 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.MethodsThis 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 cm2 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.ResultsTwenty-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.ConclusionsCal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.

Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study

“…An aerosol foam formulation of fixed-combination Cal/BD has been developed as a new topical treatment option for psoriasis, with the aim of enhancing adherence and increasing the therapeutic options available. Previous studies with Cal/BD aerosol foam have shown greater in vitro drug penetration and a greater anti-psoriatic effect over 4 weeks of treatment than Cal/BD ointment and vehicle, with a comparable tolerability profile [13–16]. The phase III PSO-ABLE (LEO90100 in PSO riasis—the effect of prolonged use of calcipotriol A nd B etamethasone dipropionate combination therapy, a randomized, active- and vehic LE -controlled 12-week trial) study in patients with mild-to-severe psoriasis involving <30% body surface area (BSA) demonstrated that Cal/BD aerosol foam had superior efficacy at week 4 compared with Cal/BD gel at week 8 [17]; these timepoints are the treatment periods in the approved US Food and Drug Administration prescribing information and the European Medicines Agency summary of product characteristics, and reflect the recommended use of each formulation in clinical practice.…”

Comparison of Occlusive and Open Application in a Psoriasis Plaque Test Design, Exemplarily Using Investigations of Mapracorat 0.1% Ointment versus Vehicle and Reference Drugs

“…In many studies in which sonography was performed, evaluators measured full skin thickness, also described as distance between the skin surface and the dermis-subcutaneous tissue interface [14,12,21,26,27] and separate measurements of epidermal and dermal thickness [28]. Queille-Roussel et al [24] measured a value described as “lesion thickness”, and in other publications [23,29,30] the parameters “skin thickness” and also “echo-poor band thickness” were evaluated. The observation that the EPB corresponds to the major proportion of the acanthotic epidermis and the superficial dermis is in agreement with findings from el Gammal et al [15,16].…”

“…While sonography measurement of the EPB addresses the first aspect and erythema measurement provides an objective parameter for the second, there is no established objective measurement method available to quantify the severity of scaling, so that evaluation commonly relies on clinical grading. In many studies in which sonography measurements were made, scaling was one of several clinical parameters evaluated in addition to sonography [21,23,26,29,30]. In contrast, Bangha and Elsner [12] described a descaling procedure prior to sonography assessments, and, consequently, scaling was not scored.…”

New Calcipotriol/Betamethasone Dipropionate Foam Formulation for the Treatment of Psoriasis: An Overview

“…Combination foam treatment was considered more effective and with the same tolerability as ointment ( ACTH -Adrenocorticotropic hormone; ADRs -Adverse reactions; AEs -Adverse events; AUC -Area under the curve; DLQI -Dermatology Life-Quality Index; DTT -Difficult to treat; HR-QOL -Health-related quality of life; MDR -maximal dermal response; MCII -mean cumulative irritation index; mPASI -modified psoriasis area and severity index; pts -Patients; SAES -Serious adverse events; SD -Standard deviation; TCS -Total clinical score; y -Years difficult-to-treat areas) in patients with plaque psoriasis, a phase IIa (NCT02518048), randomized, single-centre, investigator-blinded, 4-week study was performed. 31 Cal/BD foam and BV-medicated plaster were applied once daily to six test sites. Primary efficacy endpoint was absolute change in TCS; secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes, and safety.…”