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An Applicator Delivery System for Fixed-Combination Calcipotriene Plus Betamethasone Dipropionate Topical Suspension (Gel): Innovating Psoriasis Vulgaris Treatment Through Patient Collaboration.

ABSTRACT: Treatment non-adherence is a complex problem encountered in all therapy areas, particularly in chronic diseases such as psoriasis vulgaris. To address adherence issues, focus is turning towards developing interventions tailored to individual patient needs. Topical therapies remain the mainstay of psoriasis treatment; however, these are associated with additional challenges where preparations may be perceived as messy, inconvenient and time-consuming. Once-daily fixed-combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) topical suspension is a convenient and effective first-line topical psoriasis therapy. To improve the patient experience with this treatment, we undertook a program-in collaboration with patients and healthcare professionals-to develop a topical treatment delivery system that further caters to the unmet needs of psoriasis patients. The finalized Applicator comprises: an easy to operate pump-action lever providing consistently accurate dose delivery (0.05 g of Cal/BD topical suspension/pump); a single-tip nozzle allowing for targeted, precise application to body and scalp psoriasis plaques; two spreading surfaces designed to disperse treatment evenly across both large and small affected skin areas; and a protective cover. Patients listed the following as key Applicator attributes: ease of use, 'less messy' treatment, precise application, consistent accurate dosing, 'no touch' treatment, reduction of wasted treatment and extended length of reach for awkward areas. Although these attributes were well received by most patients and healthcare professionals, some patients did not perceive them all as improvements over their current treatment; this highlights the need to tailor treatment for each individual patient's requirements. For patients who prefer using the Applicator, it has the potential to provide greater control over their daily psoriasis management by providing a simple, convenient treatment option, with minimal impact on their lives. The Applicator may represent a more acceptable treatment delivery system for some patients with psoriasis vulgaris and may, therefore, promote long-term treatment adherence.

Funding

LEO Pharma.

SUBMITTER: Rasmussen G

PROVIDER: S-EPMC4674455 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:An aerosol foam formulation of fixed combination calcipotriol 50 ?g/g (Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) has been developed for psoriasis vulgaris treatment.To compare Cal/BD aerosol foam pharmacodynamic activity with Cal/BD ointment and with other topical corticosteroids of different potencies by assessing vasoconstrictor potential.A Phase I, single-centre, investigator-blinded, vehicle-controlled, intra-individual comparison vasoconstriction study. Healthy volunteers received a single application on selected sites of: Cal/BD aerosol foam, clobetasol propionate 0.5 mg/g cream (CP; very potent), Cal/BD ointment (potent), fluocinolone acetonide 0.25 mg/g ointment (FA; moderately potent), BD aerosol foam and aerosol foam vehicle. A seventh untreated site acted as a negative control. Skin blanching was assessed by visual (primary response criterion) and colorimetric a* and L* measurements (secondary criteria), and was analysed over time (6-32 h post-application).Thirty-five healthy volunteers were included. All active treatments led to significantly greater skin blanching than control. By visual assessment, skin blanching with Cal/BD aerosol foam was significantly less compared with CP cream [mean AUC0-32 2560 vs. 3831; mean difference = -1272; 95% confidence interval (CI): -1598, -945; P < 0.001], similar to BD aerosol foam (mean AUC0-32 2560 vs. 2595; mean difference = -35; 95% CI: -362, 292; P = 0.83) and significantly greater than Cal/BD ointment (mean AUC0-32 2560 vs. 2008; mean difference = 552; 95% CI: 225, 878; P = 0.001) and FA ointment (mean AUC0-32 2560 vs. 1981; mean difference = 578; 95% CI: 251, 905; P < 0.001). Colorimetric assessments a* and L* also indicated significantly reduced skin blanching with Cal/BD aerosol foam compared with CP cream. No adverse events (AEs) were reported.Cal/BD aerosol foam can be considered a more potent formulation than Cal/BD ointment and the moderately potent FA ointment, but less potent than the very potent corticosteroid, CP cream.

Project description:INTRODUCTION:Betamethasone dipropionate (BD) has anti-inflammatory, immunomodulatory, and antiproliferative activity. The aim of the current work was to test the hypothesis that the addition of corticosteroid such as BD and a keratolytic agent such as salicylic acid in nanocarrier based microemulsions formulation would result in enhancement and sustaining of corticosteroid delivery rate leading to better anti-psoriatic activity. Clinical use of BD is restricted to some extent due to its poor permeability across the skin. So to increase its permeation across the skin, microemulsion-based gel formulations were prepared and characterised. MATERIALS AND METHODS:Microemulsions were prepared by aqueous phase titration method, using oleic acid:sefsol (1.5:1), Tween 20, isopropyl alcohol, and distilled water as the oil phase, surfactant, cosurfactant and aqueous phase, respectively. Selected formulations were subjected to physical stability studies and consequently in vitro skin permeation studies. Surface studies of optimized formulation were done by transmission electron microscopy. In vivo anti-inflammatory activity was done by carageenan-induced raw paw edema method. RESULTS:The droplet size of microemulsions ranged from 60 to 190 nm. The optimized formulation exhibited viscosity 28.55 ± 2.03 mP, refractive index 1.409, pH 6.4, and conductivity 10(-4) scm(-1). The optimized microemulsion was converted into hydrogel using carbopol 934, and salicylic acid was incorporated into it. Drug deposition in skin was found to be 29.73 ?g/mg. Assessment of skin permeation was done by histopathology studies which indicated changes in the structure of epidermal membrane of skin. In vivo anti-inflammatory activity indicated 72.11% and 43.96% inhibition of inflammation in case of developed microemulsion gel and marketed gel, respectively. CONCLUSIONS:The developed microemulsion gel containing BD and salicylic acid provided sustained and good anti-inflammatory activity for the treatment of psoriasis.

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An Applicator Delivery System for Fixed-Combination Calcipotriene Plus Betamethasone Dipropionate Topical Suspension (Gel): Innovating Psoriasis Vulgaris Treatment Through Patient Collaboration.

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