Background Plaque psoriasis is a common, chronic and relapsing inflammatory skin disease clinically characterized by erythema and scaling desquamation. As over 90% of psoriasis patients benefit from topical therapies, local treatments continue to play an eminent role in management strategies. One such topical treatment is the fixed dose combination of calcipotriol (CAL) and betamethasone dipropionate (BDP). Objectives Pooled analysis of two different phase 3 clinical trails to compare superiority regarding efficacy, safety and quality of life (QoL) between CAL/BDP PAD-cream and CAL/BDP TS. MethodsThe data from two phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trials enrolling patients with psoriasis were pooled and analysed. Investigational products included a CAL/BDP cream based on PAD TM Technology (PAD-cream) designed for high skin penetration and increased patient preference, an active control (marketed CAL/BDP topical suspension/gel, in the following abbreviated as CAL/BDP TS) and cream vehicle, which were applied once daily for 8 weeks.Results Efficacy and safety of the novel CAL/BDP PAD-cream formulation for the topical treatment of psoriasis demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP TS (31.9%; P < 0.0001), the mean per cent reduction in mPASI for CAL/ BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP TS (P < 0.0001) and DLQI 0/1 was obtained by 43.8% in the CAL/BDP PAD-cream group versus 34.2% in the CAL/BDP TS group (P = 0.0005). There was no adverse drug reaction reported with a frequency of >1%, associated with the CAL/BDP PAD-cream. ConclusionsThe novel fixed dose combination CAL/BDP PAD-cream offers greater efficacy, superior patient QoL and equivalent favourable safety for the topical treatment of psoriasis, in comparison to the currently available topical suspension/gel.

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Topical formulation and delivery technologies for pharmaceutical application should simultaneously address efficacy, safety and convenience of therapy. This has historically proven to be challenging, since formulation features that drive efficacy often have undesirable consequences for safety and convenience and vice versa. Polyaphron dispersion (PAD) technology is a novel topical formulation and drug delivery system developed with the purpose of preserving these key attributes. PAD formulations are typically oil-in-water dispersions consisting of oil droplets encapsulated in a multi-molecular shell structure. This shell structure protects potentially unstable active molecules solubilized in the oil from hydrolytic degradation. Example data are presented of enhanced drug penetration from PAD formulations, including dermal delivery of calcipotriene, betamethasone dipropionate and tacrolimus as well as ocular delivery of ciclosporin A. Local tolerability is an important safety parameter for topical formulations, where high levels of surfactants can cause skin irritation. In this regard, a key benefit of PAD formulations is the inherent reduced requirement for surfactants to generate stable formulations compared to conventional emulsion systems. Patients with chronic diseases with topical manifestations such as psoriasis or atopic dermatitis have been reported to miss up to 70% of planned topical applications, mainly due to a lack of satisfaction with their therapy. Patients generally prefer light, moisturizing, non-greasy and quickly absorbed vehicles that are simple to use on all body parts. PAD formulations can generally be designed to meet these criteria. In conclusion, PAD technology provides high flexibility in topical drug design and can be applied to several body locations without compromising efficacy, safety or convenience of therapy. Clinical Trial Register : Clinicaltrials.gov: NCT03802344.

Introduction: Adherence to topical treatments for psoriasis is reported to be poor. One key contributing factor is the inconvenience associated with formulations that may be greasy, time consuming to apply, and slow to absorb. There is a paucity of patient-reported outcome measures that evaluate psoriasis patients' perceptions of treatment convenience. The Psoriasis Treatment Convenience Scale (PTCS) was therefore developed and validated. Methods: Following a literature review of issues relating to convenience of topical treatments, important items were identified and a draft version of the PTCS was developed and underwent content validity testing (n = 20). The revised scale was included in a clinical trial of topical therapy (n = 794; NCT03308799), and psychometric testing was performed. Results: The final questionnaire included five core items and one overall satisfaction question. In psychometric testing, the scale demonstrated stability across trial population, and good validity, reliability, and sensitivity. Conclusion:The PTCS is a new, reliable, sensitive, validated tool for the assessment of patient-reported treatment convenience. Use of the PTCS will facilitate evaluation of convenience as part of the clinical development of topical therapies, and thus may help to improve patient adherence and, therefore, treatment outcomes.

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