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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).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.The 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™ 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.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 of1%, associated with the CAL/BDP PAD-cream.The 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.

While many patients with psoriasis are candidates for topical agents, long-term treatment effects are unclear. This systematic review evaluated global findings from clinical trials and real-world studies of topical calcipotriol and the two-compound formulation of calcipotriol and betamethasone dipropionate for mild-to-moderate plaque psoriasis (including scalp psoriasis). PubMed, Embase and MEDLINE were searched for relevant English-language publications along with Chinese, Japanese, Korean and Latin American publication databases. Identified articles were screened by title and abstract against predefined inclusion/exclusion criteria. A narrative synthesis of key efficacy and safety findings from the full papers of selected publications was developed. Thirty-seven relevant papers were identified (25 English, 11 Chinese and one Japanese-language study) including 28 randomized controlled trials. While there was significant heterogeneity in study length, treatment intensity and clinical measures, following a critical review of the published data combined with expert opinion, the following clinical practice recommendations were agreed in order to assist healthcare providers: in adults, long-term treatment with calcipotriol/betamethasone dipropionate is well tolerated and efficacious for up to 1 year on an 'as needed' basis, and for up to 16 weeks on a fixed-treatment regimen. Calcipotriol is also well tolerated and efficacious when used long term (up to 52 weeks) 'as needed' and for up to 20 weeks on a fixed-treatment regimen. Used on an 'as needed' basis for up to 1 year, the safety and efficacy profile of fixed-dose combination calcipotriol/betamethasone dipropionate is more favorable than calcipotriol alone; regular consultation between patients and their dermatologist/primary care physician is required to review psoriasis symptoms and adjust treatment accordingly; a specific treatment goal should be agreed on initiation of topical agent(s) to determine when long-term treatment can begin or if a regimen change is warranted; and application frequency during the continued treatment phase should consider the patients' treatment expectations and goals.

The fixed-dose combination calcipotriol (Cal; 50 µg/g) plus betamethasone dipropionate (BD; 0.5 mg/g) ointment and gel formulations have well-established efficacy profiles in the treatment of psoriasis vulgaris (chronic plaque psoriasis); this combination has been shown to produce favourable outcomes versus either monotherapy. To improve upon the efficacy and cosmetic acceptability of these treatments Cal/BD foam was developed, demonstrating superior efficacy in Phase II/III studies compared with either of its monocomponents, Cal/BD ointment, Cal/BD gel and various other therapies for the treatment of psoriasis. Multiple outcome measures were evaluated in the clinical studies, including physician's global assessment of disease severity and modified psoriasis area and severity index. Of note, 38-55% of patients across studies achieved a physician's global assessment of 'clear' or 'almost clear' after 4 weeks of Cal/BD treatment. This superior efficacy was not associated with an increased frequency or severity of adverse events, and there was no evidence for dysregulation of the hypothalamic-pituitary-adrenal axis or calcium homeostasis. Overall, Cal/BD foam was efficacious, with a good tolerability profile consistent with established Cal/BD formulations.

The physical symptoms of psoriasis vulgaris (chronic plaque psoriasis), such as itch and itch‐related sleep loss, and the psychological impact of visible plaques on the body, all contribute to significantly reduced health‐related quality of life (HRQoL) in patients with psoriasis. In fact, the deterioration of HRQoL in patients with psoriasis is similar to patients with other chronic conditions, such as cancer and cardiovascular diseases. Rapid and effective improvements in HRQoL and itch‐related outcomes would therefore be highly valued by patients and may even improve adherence to treatment. In this article, we summarise previously published data assessing the impact of fixed‐dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch relief, quality of sleep, onset of action and HRQoL. Findings across multiple analyses indicate that Cal/BD foam provides significant improvements in itch, itch‐related sleep loss and HRQoL compared with vehicle foam or Cal/BD gel comparators. Additionally, the benefits of Cal/BD foam were recorded earlier than these comparators, often within 1 week of treatment, indicating a rapid onset of action. With the published data to hand, it is clear that Cal/BD foam provides significant improvements in the outcomes that matter most to patients and should be considered an effective topical treatment for psoriasis., Video abstract

Epidermolysis bullosa (EB) is the umbrella term for a group of rare inherited skin fragility disorders caused by mutations in at least 20 different genes. There is no cure for any of the subtypes of EB resulting from different mutations, and current therapy only focuses on the management of wounds and pain. Novel effective therapeutic approaches are therefore urgently required. Strategies include gene‐, protein‐ and cell‐based therapies. This review discusses molecular procedures currently under investigation at the EB House Austria, a designated Centre of Expertise implemented in the European Reference Network for Rare and Undiagnosed Skin Diseases. Current clinical research activities at the EB House Austria include newly developed candidate substances that have emerged out of our translational research initiatives as well as already commercially available medications that are applied in off‐licensed indications. Squamous cell carcinoma is the major cause of death in severe forms of EB. We are evaluating immunotherapy using an anti‐PD1 monoclonal antibody as a palliative treatment option for locally advanced or metastatic squamous cell carcinoma of the skin unresponsive to previous systemic therapy. In addition, we are evaluating topical calcipotriol and topical diacerein as potential agents to improve the healing of skin wounds in EBS patients. Finally, the review will highlight the recent advancements of gene therapy development for EB.

Background Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep. Objective We evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle. Methods We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks. Results Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n = 610; foam vehicle, n = 190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R2 = 0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P 40 and sleep loss >20, improvements in itch-related sleep loss occurred at Week 1 and continued through 4 weeks. Itch-related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD-foam- vs. foam-vehicle-treated patients with baseline DLQI >10 (n = 172 vs. n = 50) achieving DLQI ≤1 (25.0% vs. 4.0%; P = 0.001) and DLQI 0 (17.4% vs. 2.0%; P = 0.006) at Week 4. Conclusion Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.

Background Photodynamic therapy (PDT) is a highly effective treatment option for patients with actinic keratoses (AK). However, efficacy can be reduced by insufficient illumination or hyperkeratotic nature of lesions. Objectives To investigate if PDT combined with a topical intervention is superior to monotherapy in terms of efficacy and tolerability. Methods A systematic literature research was conducted in Medline, Embase and CENTRAL. Pertinent trial registers were hand-searched for eligible randomized controlled trials (RCTs) until 20 August 2018. Results were pooled using a random effects model to calculate relative risks (RR) or mean differences. The risk of bias was assessed with the Cochrane Risk of Bias Tool. The quality of evidence was estimated for each outcome of interest according to GRADE. Results Out of 1800 references initially identified, 10 RCTs with a total sample size of n = 277 were included. Four studies investigated a combination of PDT with imiquimod cream, three with 5-fluorouracil cream and one each with ingenol mebutate gel, tazarotene gel and calcipotriol ointment, respectively. Patients treated with a combination showed higher participant complete (RR 1.63; 95% CI 1.15-2.33; P = 0.007) and partial clearance rates (RR 1.19; 95% CI 0.84-1.67; P = 0.33). Similarly, the lesion-specific clearance was higher for PDT plus topical intervention compared to monotherapy (RR 1.48; 95% CI 1.04-2.11; P = 0.03). A subgroup analysis was performed for PDT combined with imiquimod, revealing an increased participant complete clearance rate compared to monotherapy (RR 1.57, 95% CI 1.09-2.25, P = 0.02). PDT-induced pain and local skin reactions after treatment were poorly reported. The studies were estimated at high risk for performance and detection bias. Conclusion The combination of PDT with another topical drug intervention does improve AK clearance rates compared to either monotherapy alone. This study highlights that the sequential application of two field-directed treatments represents an efficient approach in patients with multiple AK and field cancerization.

Impaired function of filaggrin (FLG) is a major predisposing factor for atopic dermatitis (AD). Several studies on FLG-deficient (Flg-/- ) mice have indicated an essential role for FLG in the skin barrier and the development of AD, but none of the studies have described the characteristics on Flg-/- mice with calcipotriol (CPT)-induced atopic dermatitis, which restricts the comprehensive understanding of functions of FLG. The present study sought to generate Flg-/- mice and applied CPT to produce AD-like dermatitis for in vivo analysis of the FLG functions. CPT was applied on the skin of Flg-/- mice to establish the AD-like dermatitis mouse model. The lesion inflammation was evaluated by gross ear thickness, histopathology, immunofluorescence, and cytokine production. Also, mucopolysaccharide polysulfate (MPS) and ceramide were used to observe the therapeutic function in this model. The results showed that the inflammation of CPT-induced dermatitis in Flg-/- mice was more severer than that of wild-type (WT) mice, as evident by the increased level of gross appearance, ear thickness, inflammatory cell infiltration (mast cells and CD3+ T cells), and inflammatory cytokine expression (interleukin (IL)-4, IL-6, IL-13, and thymic stromal lymphopoietin (TSLP)). The emollients MPS and ceramide partially restored the epidermal function and alleviated the skin inflammation in Flg-/- mice with CPT-induced AD-like dermatitis. The current study demonstrated that skin barrier protein FLG is critical in the pathogenesis of AD. Also, the AD mouse model induced by CPT in Flg-/- mice could be utilized to search for drug targets in AD.

Calcipotriol, calcitriol and tacalcitol are topical vitamin D analogues commonly used to treat psoriasis1 . As clinicians, although the treatments are often well tolerated, we often consent the known adverse effects1,2 such as irritation, erythema, and rarely photosensitivity. Vitamin D analogue toxicity in dogs is rarely reported with only 2 cases reported in veterinary literature3,4 , and more recently, 2 reports in dermatology literature4,5 . This is the first published study in reporting the exact number of cases and the clinical effects of vitamin D analogue toxicity in dogs.

Background Mild‐moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non‐steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI‐CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double‐blinded, placebo‐controlled randomized controlled trial (RCT) evaluating the effects of PSORI‐CM01 when added to topical calcipotriol cream. Methods People with moderate psoriasis vulgaris were randomized to receive oral PSORI‐CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants’ satisfaction and willingness to repeat were also assessed. Results The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow‐up. Participants’ baseline basic characteristics were comparable. No between‐group statistical significance was found on pre‐defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI‐CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported. Conclusions The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add‐on effects of oral CHM PSORI‐CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full‐scale RCT.

The active form of vitamin D (1α,25-dihydroxyvitamin D) acts as a steroid hormone and binds to the vitamin D receptor. This receptor is expressed in most cell types including cells in the central nervous system (CNS). Vitamin D has several functions in the body including effects on brain development, neuroprotection and immunological regulation. It has been shown that vitamin D has antiproliferative activities in different cancer cell lines. Tacalcitol and calcipotriol are synthetic analogues of 1α,25-dihydroxyvitamin D with reduced effect on calcium metabolism. The aim of this study was to analyse the effects of tacalcitol and calcipotriol on cell viability, proliferation and migration in the human glioblastoma cell line T98G. Glioblastoma is the most lethal type of primary tumours in the CNS. Both analogues decreased cell viability and/or growth, dose-dependently, in concentrations between 1 nM and 10 μM. Manual counting indicated suppressive effects by the vitamin D analogues on proliferation. Treatment with tacalcitol strongly suppressed thymidine incorporation, indicating that the vitamin D analogues mainly inhibit proliferation. Also, effects on cell migration were measured with wound-healing assay. Both calcipotriol and tacalcitol reduced the migration rate of T98G cells compared to vehicle-treated cells. However, they had no effect on caspase-3 and -7 activities, suggesting that their mechanism of action does not involve induction of apoptosis. The current results indicate that the vitamin D analogues tacalcitol and calcipotriol strongly reduce proliferation and migration of human glioblastoma T98G cells, suggesting a potential role for this type of compounds in treatment of brain cancer.

BACKGROUND Very few studies have assessed the efficacy of excimer in the treatment of palmoplantar psoriasis (PPP), and none has compared the excimer with calcipotriol-clobetasol propionate combination. PURPOSE To compare the effectiveness and safety of excimer lamp vs topical ointment containing calcipotriol (0.005% w/w) and clobetasol propionate (0.05% w/w) combination in PPP. METHODS This right-left randomization trial included 36 patients with PPP, who received treatment with excimer lamp (twice weekly) on one side and calcipotriol-clobetasol combination (once daily) on another side for 12 weeks, followed by 8 weeks of follow-up. Recruitment and response assessment was done by 2 experienced dermatologists (SD and TN) using modified palmoplantar pustular psoriasis area and severity index score (mPPPASI, originally devised for palmoplantar pustulosis, suitably modified to assess response in PPP). Primary outcome measure was percentage improvement in mPPPASI at 12 weeks, which was classified as minimal (≤25%), mild (>25%-50%), moderate (>50%-75%), and marked (>75%). Secondary outcome measures were the proportion of patients achieving >75% reduction in mPPPASI and the time taken to achieve it. RESULTS Of 36 recruited patients, 33 completed treatment and 21 adhered to 8-weeks follow-up. The mean mPPPASI on the excimer-treated sides reduced significantly from 7.75 ± 4.62 to 4.01 ± 4.07 (P

SummaryBackground Calcipotriol, a synthetic vitamin D analogue, is widely used for the topical treatment of psoriasis. It often causes irritant reactions, whereas allergic contact dermatitis has less commonly been reported. Objectives To report on 6 patients (among them an 11-year-old child) who presented with eczematous lesions complicating pre-existing dermatitis, observed in our tertiary referral patch test clinic between 2004 and 2016. Methods Patch tests were performed with the commercial preparation used by the patients and/or its ingredients, including calcipotriol (2 or 10 µg/ml in isopropyl alcohol), according to ESCD patch test guidelines. Results Allergic contact dermatitis was confirmed in all cases, and the lesions improved following treatment with topical corticosteroids and/or oral medication. Conclusions When topical treatment with calcipotriol fails to improve, or even worsens, existing skin lesions, contact allergy should be suspected. A patch test concentration of 2 µg/ml in isopropyl alcohol seems to be the most suitable. According to the literature, patients sensitized to calcipotriol may tolerate topical therapy with other vitamin D3 analogues, particularly tacalcitol.

Existing guidelines form no consensus for alopecia areata (AA) treatment due to the absence of a universal standard treatment and arbitrary selection of reference arms in randomized control trials (RCTs). The aim is to identify the best treatment and to rank treatments using systematic review and network meta-analysis. Data were extracted by the two investigators independently. Odds ratio (OR) of treatment success rate was pooled using the frequentist weighted least squares approach to random-model network meta-analysis. RCTs providing data of treatment success rate from PubMed, EMBASE, Web of Science, and manual search were included. About 54 RCTs consisting of 49 treatments and 3149 patients were included. Pentoxifylline plus topical corticosteroids had the highest treatment success rate compared with "no treatment," followed by pentoxifylline alone, topical calcipotriol plus narrowband ultraviolet radiation B phototherapy, topical calcipotriol, intralesional corticosteroids, systemic corticosteroids, minoxidil plus topical corticosteroids, topical bimatoprost, psoralen ultraviolet radiation A phototherapy, and tofacitinib. Even with the network meta-analysis, the best treatment because of independent loops and wide confidence intervals could not be identified. Treatment options above may be reasonable strategies, but further comparison is required.

A local epidemiological survey of psoriasis was conducted from 19 February to 30 June 2016 in Matsumoto city, Nagano Prefecture, Japan. Patients were predominantly male (268 cases, 71.5% males vs 107 cases, 28.5% females). We estimated that the prevalence of psoriasis was 0.097% in the Matsumoto area. The clinical types of psoriasis identified were psoriasis vulgaris (90.7%), psoriatic arthritis (5.9%), pustular psoriasis (2.1%), guttate psoriasis (1.0%) and psoriatic erythroderma (0.3%). The topical therapeutic agents included corticosteroids (84.0%), vitamin D3 analogs (61.5%), and a combination of calcipotriol and betamethasone dipropionate (31.0%). Current systemic treatments included cyclosporin (9.0%), etretinate (7.4%) and methotrexate (1.3%). Biologic treatments included adalimumab (4.0%), ustekinumab (2.7%), infliximab (1.3%) and secukinumab (0.8%). Ultraviolet B therapy (11.3%) was the predominant phototherapy in which narrow band ultraviolet B therapy accounted for the majority, followed by psoralen and ultraviolet A therapy (1.0%). According to the recent evolution of psoriasis treatment, the use of biologics has been increasing. This study demonstrates the changes of treatment trends of psoriasis in a non-metropolitan regional area.

Background Vitamin D analogues and NBUVB phototherapy are both well-established modalities of treatment in psoriasis. The objective of this open label, intra individual, left right study was to compare two different Vitamin D analogues, calcipotriol and tacalcitol, in combination with NBUVB phototherapy in chronic stable plaque psoriasis. Methods Thirty patients with stable plaque psoriasis were enrolled for a 12 week clinical trial. The target lesion on left side was treated topically with tacalcitol ointment once daily, while that on the right side was treated with calcipotriol ointment twice daily. NBUVB phototherapy was given thrice weekly. Efficacy was assessed by target plaque scoring. Results Both therapies resulted in statistically significant reduction in erythema, scaling, thickness and target plaque score, seen as early as 2 weeks into therapy. However, Calcipotriol combination led to an earlier clearance of plaques and a lesser relapse rate than tacalcitol combination. The number of treatment sessions and cumulative NBUVB doses were significantly lower in the calcipotriol-treated group. Conclusion Both vitamin D analogues appear to be safe, effective and cosmetically acceptable, calcipotriol being more efficacious, well tolerated with a rapid onset of action and a better maintenance of response. This article is protected by copyright. All rights reserved.

Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies, research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents. The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes (PROs). The Embase and PubMed databases were searched for articles published between 2001 and 2016 that made direct head-to-head comparisons of different formulations of an active pharmaceutical ingredient (API), focusing on clinical outcomes and PROs. In total, 22 publications on APIs or API combinations met the eligibility criteria (19 head-to-head clinical trials, one pooled analysis, one health-economic modelling study and one systematic review). Significant clinical benefit associated with the use of a reformulated API over an older formulation was reported in three trials of clobetasol propionate, one trial of calcipotriol, three trials of betamethasone and five trials/pooled analyses of calcipotriol/calcipotriene + betamethasone dipropionate (Cal/BD) formulations. Significantly improved PROs associated with the use of a reformulated API over an older formulation were reported in three trials of clobetasol propionate, one trial of betamethasone valerate and two trials of Cal/BD formulations. These results demonstrate that the innovative reformulation of APIs used in the treatment of psoriasis can produce therapies that attain significantly improved clinical outcomes and PROs. This suggests that improvement in topical therapy for psoriasis need not only to be achieved by the identification of new targets and the development of new APIs, but that improvement in the vehicle used to deliver existing APIs has the potential to result in significant clinical and patient benefits.

Background There is a lack of response data for topical treatments for psoriasis vulgaris in Asian patients. Objectives To determine the optimal maintenance regimen for topical treatment with calcipotriol monohydrate/betamethasone dipropionate gel in Korean patients with psoriasis vulgaris, by comparing the efficacy of three 8-week maintenance regimens. Methods This was a multicentre, prospective, randomized, controlled, parallel-group, open-label, phase 4 clinical trial, conducted in South Korea. Patients with psoriasis vulgaris on the limbs/trunk received once-daily treatment with calcipotriol monohydrate (50 μg/g)/betamethasone dipropionate (500 μg/g) gel for 8 weeks (induction phase). Responders (defined as an Investigator's Global Assessment of Disease Severity (IGA) grade of ‘clear’ or ‘almost clear’) were then randomized to receive 8 weeks’ maintenance treatment with Xamiol® gel once daily as needed [pro re nata (PRN Group)], once daily every day (Continuous group), or twice weekly – on Saturday and Sunday (Weekend group). The primary endpoint was the percentage of IGA responders at week 16. Results At the end of the induction phase, 62.18% of patients were IGA responders. At the end of the maintenance phase (week 16), the responder rate was 63.89% for the PRN group, 67.5% for the Continuous group and 31.43% for the Weekend group. The PRN and Continuous groups were statistically superior to the Weekend group (P = 0.0109 and P = 0.0015), but the PRN and Continuous groups did not differ statistically. The incidence of adverse events did not differ significantly between the groups. Conclusion Among Korean patients with psoriasis vulgaris, maintenance treatment with calcipotriol monohydrate/betamethasone dipropionate using a continuous daily regimen or an ‘as needed’ daily regimen provided similar efficacy, whereas a twice-weekly regimen was significantly less efficacious than either of these regimens.

BACKGROUND Guidelines for photodynamic therapy (PDT) recommend pretreatment with curettage/debulking to enhance intracellular formation of protoporphyrin IX (PpIX). However, studies suggest that new chemical pretreatment procedures may replace curettage/debulking. PURPOSE To investigate how pretreatment with curettage and two combination ointments containing calcipotriol/betamethasone and salicylic acid/betamethasone affect PpIX fluorescence after the application of methyl aminolevulinate MAL and 5-aminolevulinic acid (BF-200 ALA). METHODS Four fields on the forearms of 30 healthy volunteers were pretreated with curettage or short-term application of calcipotriol/betamethasone or salicylic acid/betamethasone for 20 min. Two fields were not pretreated, thus serving as reference. After pretreatment, MAL or BF-200 ALA was applied for 24 h, and PpIX fluorescence was measured hourly from 1 to 5 h and after 18, 21 and 24 h. RESULTS Curettage significantly enhanced PpIX fluorescence for MAL from 1 to 21 h (P < 0.0041). For BF-200 ALA, curettage enhanced fluorescence from 1 to 5 h (P < 0.000064), while fluorescence was lower from 18 to 24 h. Pretreatment with salicylic acid/betamethasone and calcipotriol/betamethasone before BF-200 ALA application did not increase PpIX fluorescence from 1 to 5 h compared to no pretreatment, and both were significantly inferior to curettage (P < 0.0017 and 0.0024, respectively). CONCLUSION Curettage significantly enhances PpIX fluorescence from 1 to 5 h and is superior to short-term chemical pretreatment. Our results support curettage as standard pretreatment in PDT.

Erythrosis pigmentosa peribuccalis is an infrequent condition, with fewer than 35 cases reported in the literature, that affects mainly women. It presents as small papules that form a hyperpigmented plaque around the mouth and nose. Little is known about the etiology of this condition, its dermoscopic characteristics have not been described, and no effective treatment has been reported. We report a 15-year-old girl with this rare dermatosis who was successfully managed with daily calcipotriol, weekly topical ivermectin, and strict photoprotection. We also describe for the first time the dermoscopic findings of this entity.

Topical and systemic agents have dramatically improved the treatment efficacy of psoriasis. Few reports, however, exist describing the economic burden in Japanese psoriatic patients. The aim of the study was to evaluate the total costs as well as cost versus efficacy of topical and systemic treatments of psoriatic patients under the Japanese health insurance system. The retrospective study was performed from the database of our clinic, which is located in Hokkaido Prefecture. Cost and effectiveness of psoriatic patients were evaluated during the 12-month period from April 2015 to March 2016. Data were collected and calculated for the total cost per year, treatment efficacy and cost versus efficacy. The mean total cost of topical corticosteroid treatment was ¥18 184/year and was lowest among the treatments. The systemic treatment with biologics was most expensive and the costs were over ¥400 000/year. Among the topical treatments, calcipotriol/betamethasone dipropionate was most expensive (¥34 693/year). However, cost versus efficacy was not significantly different from that of topical corticosteroid treatments. The cost of secukinumab was highest among all the treatments (¥631 600/year). However, treatment day per cost was lowest of all the psoriasis treatments. Biologics showed the highest cost than topical or systemic treatments. However, they showed most marked efficacy in terms of improving the psoriatic skin lesions.

The vitamin D analogue calcipotriol is an immunomodulatory drug widely used to treat psoriasis; however, how calcipotriol affects the immune cells in psoriasis lesions is not fully understood. The aim of this study was to investigate the effect of calcipotriol on the frequency of CD4(+) and CD8(+) T cells and innate lymphoid cells (ILC) and their production of IL-17A, IFN-γ and IL-22 in psoriasis lesions in patients with chronic plaque psoriasis. Eighteen patients with psoriasis were included, and two similar psoriasis lesions were chosen for each patient. One lesion was treated with calcipotriol (50 μg/g) and the other with vehicle twice a day for 14 days. The clinical effect was measured by degree of erythema, scaling and induration in each lesion (SUM score). Skin biopsies were collected for histological and immunohistochemical analyses. Skin-derived cells were isolated and analysed by flow cytometry. After 14 days of treatment with calcipotriol, a significant clinical and histological effect was seen; however, we found no differences in the frequency of CD4(+) and CD8(+) T cells or ILC between calcipotriol- and vehicle-treated skin. The main finding was a significant decrease in CD8(+) IL-17(+) T cells in skin-derived cells from calcipotriol-treated skin, which was further supported by the absence of CD8(+) IL-17(+) T cells in immunohistochemical staining of calcipotriol-treated skin. No changes in the frequency of IL-22(+) or IFN-γ(+) cells were observed. Our findings show that the vitamin D analogue calcipotriol reduces the frequency of CD8(+) IL-17(+) T cells in psoriasis lesions concomitant with clinical improvement.

Conflicts of interest: K. Togsverd-Bo and C. Bay have received traveling grants from Galderma. C. Bay has within the past 3 years been employed at LEO Pharma A/S, Denmark, but has no competing financial or other interests related to the preparation or the content of the manuscript. M. Haedersdal and H. C. Wulf declare to have received research funding and lecture honoraria from LEO Pharma A/S and Galderma. C. M. Lerche has no conflict of interest.

Background Narrow-band ultraviolet B (NB-UVB) is an effective and safe treatment for vitiligo. Calcipotriol, a synthetic analogue of 1,25 dihydroxyvitamin D3 may regulate melanin synthesis. Several clinical studies have been conducted but the synergistic effect of addition of calcipotriol to NB-UVB in the treatment of vitiligo is still debatable. Objectives To compare the efficacy and safety of topical calcipotriol (0.005%) in combination with NB-UVB vs. NB-UVB alone in generalized vitiligo. Methods A prospective right–left comparative study including 27 patients of vitiligo was conducted for 24 weeks. On one side, calcipotriol was applied twice a day. NB-UVB was administered thrice a week. Response to treatment was assessed using change in Lund and Browder (L&B) score for percentage reduction in body surface area, investigator's global assessment (IGA) and patient's global assessment (PGA) scores. Treatment related side effects were noted. Results Mean percentage reduction in L&B score at 24 weeks was 51.4% on NB-UVB and 49% on NB-UVB plus calcipotriol side (P = 0.557), mean IGA score on NB-UVB was 2.7 ± 0.5 and on NB-UVB plus calcipotriol was 2.6 ± 0.4 (P = 0.821) and mean PGA score on NB-UVB side was 5.6 ± 3.4 and on NB-UVB plus calcipotriol side was 5.8 ± 3.2 (P = 0.706). Perifollicular repigmentation that matched with the surrounding normal skin colour was seen in majority of patients on both treatment sides. Calcipotriol produced mild local adverse effects. Conclusions Addition of calcipotriol to NB-UVB probably does not enhance the efficacy of treatment including extent of repigmentation and time to initial repigmentation. Larger, randomized placebo-controlled trials are required to determine whether addition of calcipotriol has any utility when administered with NB-UVB in the treatment of vitiligo.

Clinically, oral Chinese herbal medicine (CHM) is widely used in the treatment of psoriasis. This review evaluates the effects of oral CHM in combination with pharmacotherapy for psoriasis vulgaris. The Cochrane Library, PubMed, Embase, CINAHL, CNKI, and CQVIP were searched from their inceptions to November 2012. Randomized controlled trials (RCTs) investigating CHM plus pharmacotherapy compared to pharmacotherapy were included. Data were analyzed using Review Manager 5.1.0. Seventeen RCTs were included, conducted in China, and employed a diversity of both herbal medicines and pharmacotherapies. When the meta-analyses were restricted to studies that used a well-known pharmacotherapy as the comparator with 60% or greater clinical improvement in psoriasis as the outcome, five studies used oral acitretin, one used topical calcipotriol, and one used topical clobetasol propionate as control interventions. At the end of treatment, there was a benefit for the pooled result of the five studies that compared CHM plus acitretin with acitretin alone and no serious adverse events were reported. However, none of these studies was blind, so there is considerable risk of bias in this result. In addition, there was inadequate reporting of longer-term results, so it remains unclear whether the reported effect could be maintained or whether the prolonged use of the CHM in conjunction with acitretin would be safe. The main plants used in these studies, Rehmannia glutinosa root, Salvia miltiorrhiza root, and Lithospermum erythrorhizon root, have shown anti-inflammatory and/or antiproliferative effects in experimental studies. These actions may at least partially explain the observed results.

Background/Objective This post hoc analysis examined the effects of adalimumab in patients with scalp and/or nail psoriasis from BELIEVE (a randomized, controlled, multicentre phase 3 safety and efficacy trial). Methods Efficacy was assessed in the pooled treatment group (adalimumab with or without calcipotriol plus betamethasone dipropionate) by Psoriasis Area and Severity Index (75% improvement; PASI 75), Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI), Dermatology Life Quality Index (DLQI) and a visual analog scale (VAS) for pain. Results Of the 730 enrolled patients, 663 (91.3%), 457 (63.1%) and 433 (60.1%) had psoriasis of the scalp, nails, or both, respectively. Similar proportions of patients with (68.2%) and without (63.5%) scalp involvement achieved a PASI 75 response at week 16 [adjusted odds ratio (OR), 1.34; P = 0.320]. PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 (53.0% vs. 62.9%; OR, 0.68; P = 0.019) and week 16 (65.0% vs. 73.0%; OR, 0.70; P = 0.052). PASI 75 response rates were 66.1% in patients with scalp and nail involvement and 70.8% in patients without both scalp and nail involvement at week 16 (OR, 0.87; P = 0.423). Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study. Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median (mean ± SD) decrease from baseline PSSI at week 16 of 100% (77.2 ± 96.9%). Patients with nail psoriasis improved, demonstrated by a median (mean ± SD) decrease from baseline NAPSI at week 16 of 39.5% (9.4 ± 164.5%). Conclusion Our results indicate that adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement. In addition, similar PASI 75 response rates are achieved in patients with and without scalp involvement, whereas patients with nail involvement demonstrate a moderate (perhaps delayed) PASI 75 response rate.

Treatment non-adherence is a general challenge and a complex problem. It is a key factor that impacts the 'real-life' effectiveness of topical treatments for chronic disorders, such as psoriasis. Here, we provide our expert opinion on the real-life effectiveness of topical psoriasis treatment, using the fixed combination gel (Daivobet(®) gel; calcipotriol plus betamethasone dipropionate) as a case study. The fixed combination gel is a first-line topical treatment for mild-to-moderate psoriasis, developed to be the gold-standard therapy for psoriasis patients. This fixed combination gel is an effective and well-tolerated topical psoriasis treatment that the majority of our patients prefer to the ointment formulation. We assessed our real-life experience and considered any gaps between daily practice and clinical trials data. We recommend a multifaceted approach to improve real-life effectiveness and bridge the gap between investigational trials and treatment reality and propose the following recommendations: (1) educate primary healthcare providers on how to effectively manage topical psoriasis treatment and the patients who use the treatment; (2) educate the patient on why treatment needs to be maintained, even when symptoms improve; and (3) provide a supportive environment that will not allow the patient to feel abandoned. A patient-centric approach may improve adherence, which will lead to patients receiving more effective treatment for psoriasis.

Background Psoriasis is most often treated using topical therapies such as the once-daily fixed combination of calcipotriol and betamethasone dipropionate, which is available as a gel and an ointment. To date, there have been no direct comparisons of patient perspectives on the two formulations. Objective To describe and compare patients' perspectives on calcipotriol and betamethasone gel and ointment formulations, including real-life effectiveness, adherence behaviour, treatment satisfaction and health-related quality of life (QoL), during long-term psoriasis vulgaris management, according to interim findings from the PRO-long study. Methods PRO-long is a multicentre, prospective, observational, 52-week cohort study in patients prescribed fixed-combination calcipotriol (50 μg/g) and betamethasone (0.5 mg/g; as dipropionate) gel or ointment for long-term psoriasis management. Difference in effectiveness at 4 and 12 weeks was assessed by comparing the proportion of patients with controlled (mild or very mild) disease, according to the Patient's Global Assessment. Additional patient questionnaires were used to assess adherence behaviour, treatment satisfaction (nine-item Treatment Satisfaction Questionnaire for Medication) and health-related QoL (Skindex-29). Results A total of 156 patients were included in the analysis. In single items of the adherence behaviour and treatment satisfaction questionnaires, patients preferred the gel over the ointment as convenient, easy to use and fast to apply. Post hoc analysis demonstrated significant differences between gel and ointment for convenience and application time. More patients had controlled disease at week 12 with gel (71.9%) vs. ointment (65.7%); however, the difference was not statistically significant (primary end point; P = 0.40). Conclusion This interim analysis supports fixed-combination calcipotriol and betamethasone gel as more convenient, easier to use and faster to apply than the ointment formulation in real-life conditions according to patients with psoriasis vulgaris. Furthermore, a numerical difference in patient-reported real-life effectiveness was seen in favour of the gel, although this was not statistically significant.

Background A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP). Methods This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol–betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients’ quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group. Results Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a −0.288 (95% CI: −0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group. Conclusions BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients’ psoriasis and QoL.

A rapid and sensitive liquid chromatography-tandem mass spectrometric method to evaluate the permeation and retention of calcipotriol in excised samples of pig, rat and mouse skin after application of a calcipotriol ointment has been developed and validated. After sample preparation of ointment, skin homogenate and receptor medium by liquid-liquid extraction, chromatography was performed on an Extend-C18 column using isocratic elution. Detection was by electrospray ionization in the negative ion mode using multiple-reaction monitoring of the precursor to product ion transitions of calcipotriol at m/z 411.1 → 393.5, and of lovastatin (internal standard) at m/z 403.2 → 101.2. The assay was linear in all matrices with LLOQs of 1, 0.5 and 40 ng/mL for skin homogenate, receptor medium and ointment samples respectively. In terms of the permeation profiles, it was found that calcipotriol permeated through all skins to only a limited extent over 20 h after application but was efficiently retained in all skins at a level at 20 h of between 40% (pig) and 60% (rat and mouse) of the applied dose. This indicates that calcipotriol ointment has the potential to provide sustained therapeutic benefit in the treatment of psoriasis with minimal systemic side effects.

Summary Background The successful treatment of psoriasis depends not only on the efficacy of the medication but also on patientsi acceptance and adherence to the prescribed regimen. Patients and Methods In this non-interventional, prospective trial 579 patients with psoriasis were treated once daily with the fixed combination of calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Daivobet® Gel) for 4 weeks. Comparing the new medication to their previous treatment, patients assessed their quality of life by means of the Dermatology Life Quality Index (DLQI), reported their therapy- associated burden in daily life by the Psoriasis Disability Index (PDI) and assessed how easy the new medication was to employ. Disease severity was rated at the start and end of the study by physicians and patients using a Global Assessment (PGA from 0–5 points) and the Body Surface Area (BSA) assessed by the physicians. Results Quality of life improved from 8.7 to 3.2 points (p 4% before vs. 37.3% after therapy). The application of the study medication was 30% less time-consuming and handling associated with significantly higher patient satisfaction. Efficacy and tolerability of Daivobet® Gel versus prior treatment were judged “very good” in 85.7% vs. 27.6% of patients. Conclusions The study substantiates a significant improvement of the quality of life during therapy with the fixed combination. Patients benefit from the convenience and time-saving as compared to their prior treatment. Thus, Daivobet® Gel can be recommended as an effective and well-tolerated treatment which may easily be integrated into daily life of patients with psoriasis.

We compared the clinical efficacy of various psoriasis treatments among: (i) topical application of calcipotriol ointment twice daily (group I); (ii) topical application of calcipotriol ointment twice daily and narrowband ultraviolet B NB-UVB phototherapy once a week (group II); (iii) topical application of heparinoid ointment twice daily and NB-UVB phototherapy more than twice a week (group III); and (iv) topical application of calcipotriol ointment twice daily and NB-UVB phototherapy more than twice a week (group IV). Ten patients were randomly selected for each group and treated by the indicated regimens for 12 weeks. All treatments were effective and significantly improved Psoriasis Area and Severity Index (PASI) scores, self-administered PASI scores and visual analog scale scores of pruritus. Group IV showed most marked and rapid reduction in PASI and self-PASI scores among the four regimens. Although the serum levels of interleukin (IL)-17, IL-20 and IL-22 and psoriasis disability index were significantly decreased after the treatments, no significant difference was detected among the four groups. Our study indicates that combination of calcipotriol ointment plus NB-UVB more than twice a week is superior to other treatment regimens, rapidly improving psoriasis lesions.

Background Most psoriasis patients suffering from mild to moderate disease are treated with first-line topical treatments, including corticosteroids, vitamin D analogues, topical retinoids and calcineurin inhibitors. Although evidence-based guidelines on combinations are lacking, the majority of patients will be treated with combinations of these popular topicals at some point during their life-long treatment. Objectives We intended to systematically review all available literature on the efficacy and safety of combinations of first-line topicals in chronic plaque psoriasis, and ultimately, to propose recommendations for combined regimens concerning first-line treatments. Methods Databases used as data sources were PubMed, EMBASE and the Cochrane Controlled Clinical Trial Register. According to standardized procedures, literature searches were performed and a level of evidence was determined. Results In total, 2918 publications on topical combination therapy were revealed, of which 45 articles on first-line combinations were included. The combination of potent and superpotent corticosteroids with vitamin D analogues provides an improvement of psoriasis within 2 weeks, reaching a maximal improvement after 4 weeks in the majority of patients. The two-compound product permits once-daily treatment and therefore is a good solution for chronic plaque psoriasis including scalp psoriasis. Combinations of corticosteroids, with tazarotene or with calcineurin inhibitors do not provide an advantage above corticosteroid monotherapy. Conclusion The combination of potent corticosteroids with calcipotriol has been studied most extensively and should be regarded as an efficacious and safe treatment option with the two-compound products as the most practical solution.

We present the case of a 5-year-old boy who presented with systematized epidermal nevus with evidence of epidermolytic hyperkerato- sis on skin biopsy. He was otherwise well, with normal growth and development and no evidence of other organ system involvement. He had experienced only mild improvement with potent topical corticosteroids. He reported more-marked improvement after 2 months of topical calcipotri- ol ⁄betamethasone dipropionate combination ointment once a day to the lesions. Extensive epidermal nevi can lead to severe cosmetic disfigurement. We recommend a trial of topical calcipotriol ⁄betamethasone dipropionate ointment for patients with extensive epidermal nevus not amenable to surgical treatment. Epidermal nevi are relatively common, benign epi- dermal proliferations usually present at birth or appearing in early childhood and often found along the lines of Blaschko. Although usually occurring as a single lesion, multiple lesions may be present in some patients. Systematized epidermal nevus has been used to describe extensive lesions occurring bilaterally. Histopathologi- cally, some epidermal nevi may reveal features of epi- dermolytic hyperkeratosis, indicating a mosaic mutation in keratin 1 or keratin 10 genes. Epidermal nevi are dif- ficult to treat, especially in patients with widespread involvement. We describe a case of a young boy with systematized epidermal nevus with histologic features of epidermolytic hyperkeratosis, improving with topical calcipotriol ⁄ betamethasone dipropionate combination ointment.

Background and Objectives: Psoriasis (Pso) in children may be confused clinically with atopic dermatitis (AD) and, indeed, the two conditions may co-exist. The aim of this study was to determine historical and clinical features that are different in paediatric Pso and AD and to describe children who have features of both: psoriasis-dermatitis overlap (PD). Methods: Children with features of psoriasis or eczema, or both, who were referred to paediatric outpatients and/or private rooms were evaluated. Data were collected from 170 consecutive children aged less than 12 years between July 2011 and November 2011. Participants were classified by described criteria as having Pso (n = 64), AD (n = 62) or PD (n = 44). Results: Only 9.4% of children with Pso were correctly diagnosed by the referring doctor. Children with Pso relative to AD were more likely to have had a history of scaly scalp and nappy rash in infancy, a family history of psoriasis, current scalp and periauricular rashes, defined, patchy plaque morphology and papulosquamous rashes not typical of adult psoriasis on extensor elbows and knees. Children with PD had features of both but presented most often as typical paediatric psoriasis combined with flexural eczema. Children with Pso and PD responded well to specific treatment strategies for psoriasis, including potent topical corticosteroids (TCS), calcipotriol and phototherapy. Both Pso and PD tended to require more potent TCS than AD to achieve disease suppression. Conclusion: We found that Pso and PD in children both differ clinically from AD and have identified historical and clinical features that characterise childhood Pso.

Background Topical drugs enhance the therapeutic effects of ultraviolet (UV)-based therapy for psoriasis. However, their efficacy has yet to be established in a clinical trial. Objectives This study aimed to compare the efficacy of targeted microphototherapy alone and in combination with psoralen or calcipotriol in the treatment of plaque-type psoriasis. Methods Thirty individuals, affected by plaque-type psoriasis, were treated with targeted narrowband UVB phototherapy alone (Group 1), in combination with psoralen gel (Group 2), or in combination with calcipotriol ointment (Group 3) three times per week based on predetermined minimal erythema doses for 10 weeks. Results All patients in each group completed the study. The percentages of improvement in Psoriasis Area and Severity Index (PASI) and Psoriasis Severity Index (PSI) scores were 33.9% and 38.3% in Group 1, 29.9% and 29.8% in Group 2, and 67.2% and 59% in Group 3, respectively. There was no statistically significant difference in improvement between Groups 1 and 2 (P > 0.05). Outcomes in Group 3 were found to be superior compared with those in the other groups. Conclusions The addition of calcipotriol ointment in targeted phototherapy enhances the therapeutic effects of phototherapy in the treatment of plaque-type psoriasis.

Objective The objective of this systematic review was to prepare for evidence-based recommendations on the use of vitamin D analogues, and their combination with topical steroids in psoriasis. Methods Literature systematic review performed in May 2011. The Cochrane, PubMed and Embase databases were systematically searched with different combinations: including Psoriasis AND calcipotriol expanded to all vitamin D analogues. To assess efficacy across studies, we used two predefined criteria to account for the numerous endpoints found in the literature, ‘Treatment success’ corresponding to 90% improvement in severity and ‘Satisfactory response’ corresponding to 75% improvement. We conducted a meta-analysis comparing the efficacy of vitamin D analogues plus topical steroids (VDS) vs. vitamin D analogues alone (VD). To determine the relative cost-efficacy of the topical drugs available on the market, cost/efficacy ratios were calculated for each product according to the approved therapeutic regimen. Results 51 articles were selected. The application duration varied between three to 52 weeks across studies. VD as monotherapy had a satisfactory response rate between 22% to 96% and a treatment success rate ranging from 4% to 40%. VDS had a satisfactory response rate between 35% to 86% and a treatment success rate ranging from 27% to 53%. A meta-analysis found a probability of success twice higher with VDS than with VD in adult plaque psoriasis. The cost/efficacy ratio was evaluated as 1.2–1.8 times higher for VDS than for VD. Conclusion VDS is twice more effective than VD and displays a better cost per success. Additional studies are needed to clarify maintenance treatment, impact on quality of life, treatment of non-plaque psoriasis. It will be important to harmonize outcome measures in future studies with topical agents in psoriasis to better appraise their efficacy.

This article describes a recent development in topical therapies for psoriasis and is based on a presentation given by the authors at a satellite symposium convened during the 19th Congress of the European Academy of Dermatology and Venereology, 6-10 October 2010, in Gothenburg, Sweden. Topical therapies are the mainstay of treatment for psoriasis; however, for optimal outcomes to be achieved, medications need to be used as prescribed. Patients with psoriasis often report low treatment adherence rates; the reasons for this are multifactorial, but can include specific aspects of the treatments themselves. For example, physical properties, ease of use and the vehicle in which the active ingredients are dissolved can all play a role in an individual patient's adherence to treatment. Of the available topical therapies, corticosteroids and vitamin D analogues are the treatment of choice, with combined efficacy that is superior to monotherapy with either agent. To permit simultaneous once-daily dosing, an ointment was formulated that allowed calcipotriol and betamethasone dipropionate to be delivered together; this two-compound ointment had an improved efficacy and tolerability profile vs. either compound alone. To provide an alternative for patients who may dislike ointments, but still want to benefit from the high efficacy of combination therapy, a two-compound (calcipotriol/betamethasone dipropionate) gel has recently been developed; data from phase 2 and phase 3 studies show that it is more effective than the comparators it was tested against, with fewer adverse events, and a rapid onset of action. In a series of one-to-one interviews recently conducted with 150 patients with psoriasis, gel and cream formulations were preferred for ease of use and cosmetic acceptability compared with ointment. The availability of this new gel thus increases patient choice. Ultimately, treatment should always be tailored to match individual patients' needs.

This article describes topical therapies and treatment guidelines for psoriasis and is based on a presentation given by the authors at a satellite symposium held during the 19th Congress of the European Academy of Dermatology and Venereology, 6-10 October, 2010, in Gothenburg, Sweden. The highly variable nature of psoriasis and its individual presentation in patients can make it difficult to choose the most appropriate treatment. There are many treatment options, from topical treatment with emollients for very mild psoriasis, to systemic therapy with fumaric acid esters, methotrexate or biologics for severe disease. For the treatment of mild-to-moderate psoriasis, topical therapy is generally the most appropriate and a variety of options, both historical and recent, are available. Newer therapies offer greater convenience and fewer side-effects. Of the more recently available therapies, vitamin D analogues and topical corticosteroids are the two with the greatest proven efficacy in randomized clinical trials. A recent Cochrane review showed the highest efficacy overall with the fixed combination vitamin D analogue (calcipotriol) and corticosteroid (betamethasone dipropionate). Indeed, clinical trials have shown that two-compound calcipotriol/betamethasone dipropionate ointment has higher efficacy than calcipotriol or betamethasone dipropionate alone. With regard to safety, two-compound calcipotriol/betamethasone dipropionate was shown to be suitable for intermittent long-term treatment of mild-to-moderate psoriasis. The findings of the Cochrane review are reflected in the current treatment guidelines from the USA and Germany regarding the treatment of mild-to-moderate psoriasis. In both these guidelines, which will be discussed in this article, the recommended treatments for this patient group are vitamin D analogues and corticosteroids, particularly when used in combination.

Background Few epidemiological studies are available on childhood psoriasis. Methods Between 2005 and 2008, information was collected about all children diagnosed with psoriasis in the Pediatric Dermatology Unit of Andreas Sygros Skin Hospital, in Athens, Greece. Results A total of 125 children with psoriasis were examined, the male to female ratio was 1.4 : 1 and the peak age of onset was in the 9- to 10-year-old age group. Only 16% of the patients had a positive family history. Plaque type psoriasis was the most prevalent type at presentation with 56.8% of the children affected, followed by scalp involvement (33.6%). The limbs were the most prevalent site of involvement (70 children, 56%), followed by the body (59 children, 47.2%) and scalp (60 children, 48%) equally affected. Most of the children had

Background Few large clinical studies have evaluated whether switching tumour necrosis factor antagonists (anti-TNFs) is likely to improve psoriasis in patients with prior anti-TNF treatment. Objective The aim of this subanalysis of the BELIEVE study was to assess the efficacy and safety of adalimumab for psoriasis in patients with and without previous anti-TNF treatment. Methods The BELIEVE study enrolled patients with moderate to severe psoriasis and prior failure, intolerance or contraindication to ≥2 systemic therapies. In this 16-week, double-blind, randomized, controlled trial, patients received adalimumab (80 mg, week 0; 40 mg every other week, weeks 1–15) with either topical vehicle or topical calcipotriol/betamethasone dipropionate (C/B) applied once daily for 4 weeks, then as needed. The primary endpoint was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. This post hoc subanalysis evaluated the safety and efficacy of adalimumab, with and without topical therapy, in BELIEVE patients who had prior exposure to anti-TNFs. Results Of 730 patients enrolled, 282 (38.6%) had prior anti-TNFs and 448 (61.4%) were anti-TNF-naive. Combining topical vehicle and topical C/B study populations, 61.7% of patients with prior anti-TNFs achieved PASI 75 at week 16, compared with 71.7% of anti-TNF-naive patients (P = 0.095). Adalimumab resulted in clinically meaningful improvement regardless of which prior anti-TNF agent had been used, the number of prior anti-TNFs tried, or reasons for discontinuation of prior anti-TNF therapy. Adverse event incidences were similar between patients with and without prior anti-TNF therapy. Conclusion Adalimumab was effective and well-tolerated in patients with psoriasis previously treated with anti-TNF therapy.

Enstilar (calcipotriol and betamethasone) is a new cutaneous foam formulation recently launched for the treatment of psoriasis vulgaris (plaque psoriasis) in adults. This article discusses its place in therapy, efficacy and adverse effects.

BACKGROUND: A two-compound scalp formulation containing calcipotriol (50 mug/g) and betamethasone (0.5mg/g; as dipropionate) (Xamiol, Taclonex Scalp) has been shown to be an effective and safe treatment for scalp psoriasis. OBJECTIVE: The aim of this study was to investigate the clinical efficacy of the two-compound scalp formulation after 1 week of treatment. methods: Pooled data from two large pivotal phase III trials with 2920 patients receiving once-daily treatment for up to 8 weeks with either the two-compound scalp formulation (n = 1108), betamethasone dipropionate (n = 1118), calcipotriol (n = 558), or the vehicle (n = 136) were analysed. Results: The percentage of patients who had 'absent' or 'very mild' disease according to Investigator's Global Assessment after 1 week of treatment was significantly higher with the two-compound scalp formulation (30.6%) compared to betamethasone (24.1%; P < 0.001), calcipotriol (10.0%; P < 0.001) or vehicle (6.9%; P < 0.001). Conclusion: This data indicates that the two-compound scalp formulation demonstrated significant efficacy already after 1 week, with a faster onset of effect than either of the individual components in the same vehicle, in the treatment of scalp psoriasis.

The calcipotriene/betamethasone dipropionate two-compound scalp formulation has been shown to be safe and effective in the treatment of scalp psoriasis over 8 weeks, but the patients studied were mainly White and non-Hispanic. The aim of this study was to evaluate the efficacy and safety of the two-compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients. A total of 99 Hispanic/Latino and 78 Black/African American patients were randomized double-blind in a 3:1 ratio to 8 weeks of once daily treatment of scalp psoriasis with either the two-compound scalp formulation (n=135) or its vehicle (n=42). In the two-compound group, 71.9% of patients had cleared or minimal disease at week 8 by the investigator's global assessment compared to 40.5% in the vehicle group (odds ratio 3.30; 95% CI 1.62-6.72; P