Consistency of data in six phase III clinical studies of a two-compound product containing calcipotriol and betamethasone dipropionate ointment for the treatment of psoriasis

BACKGROUND: Calcipotriol and betamethasone dipropionate are both proven products in the topical treatment of psoriasis. The efficacy and tolerability of a new ointment containing these two compounds has been assessed in six phase III clinical studies. OBJECTIVE: To compare the results obtained in the clinical studies of the new calcipotriol/betamethasone dipropionate ointment. METHODS: A total of 6050 patients with psoriasis took part in the six randomized, double-blind studies. The two-compound product was compared with each of the active constituents, either in the new ointment vehicle or in the marketed formulation. RESULTS: After 4 weeks of treatment the mean reduction in the Psoriasis Area and Severity Index (PASI) ranged from 65 to 74% with the two-compound product applied once or twice daily, from 46 to 59% with calcipotriol alone and from 57 to 63% with betamethasone dipropionate alone. The tolerability profile of the two-compound product was similar to betamethasone dipropionate monotherapy and better than calcipotriol alone. CONCLUSION: The new two-compound product containing calcipotriol and betamethasone dipropionate was found to consistently provide rapid, highly effective treatment of psoriasis vulgaris.     

Calcipotriol/Betamethasone Dipropionate

The two-compound product containing calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g (Dovobet, Daivobet) [referred to here as calcipotriol/betamethasone dipropionate], is a topical treatment for psoriasis vulgaris, combining a vitamin D analog and a corticosteroid. For most adult patients with psoriasis vulgaris on the trunk and limbs, up to 4 weeks of therapy with calcipotriol/betamethasone dipropionate provides an effective and well tolerated treatment. In clinical trials, patients with a mean baseline psoriasis area and severity index (PASI) of 9.5-10.9 experienced a mean 65.0-74.4% PASI improvement within 4 weeks, significantly better than improvements with calcipotriol 50 microg/g monotherapy, betamethasone dipropionate 0.5 mg/g monotherapy, or placebo. In addition, in 6.4%-20.1% of patients, lesions cleared. In patients who were subsequently treated with calcipotriol maintenance therapy, benefits were retained for at least 4 weeks. The safety of calcipotriol/betamethasone dipropionate in patients treated for up to 1 year was generally good; fewer than 5% of patients experienced adverse events possibly associated with long-term corticosteroid use.     

Cutaneous vascular alterations in psoriatic patients treated with cyclosporine

Videocapillaroscopy can be used to assess cutaneous microcirculation modifications in vivo, and therefore allows assessment of variations in the microvascular architecture in psoriatic subjects during treatment. The aim of this study was to observe and quantify the modifications of the superficial capillary bed in psoriatic plaques during treatment with cyclosporin A. Twelve patients with psoriasis vulgaris were treated with an initial dose of 4 mg/kg/day cyclosporin A over a period of 3 months with periodic clinical and capillaroscopic assessments. Clinical resolution of the lesions and a reduction in microcirculatory alterations was observed in 70% of patients, although none returned to a normal capillaroscopic pattern.     

An Open Label Prospective Randomized Trial to Compare the Efficacy of Coal Tar-Salicylic Acid Ointment Versus Calcipotriol/Betamethasone Dipropionate Ointment in the Treatment of Limited Chronic Plaque Psoriasis

Background:Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis.Results:Mean PASI was significantly lower at week 2 (P = 0.01) and week 4 follow-up (P = 0.05) and the mean reduction in PASI was significantly higher at week 2 (P = 0.02) with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively). There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks).Conclusion:Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.     

Videocapillaroscopy in the differential diagnosis between psoriasis and seborrheic dermatitis of the scalp

BACKGROUND: Videocapillaroscopy (VCP) can be used to explore microcirculatory modifications in skin diseases. Psoriasis shows specific capillary alterations reflecting typical histopathological changes. OBJECTIVE: To compare capillary morphology, distribution and density in psoriasis and seborrheic dermatitis of the scalp for differential diagnosis. METHODS: VCP was performed on histology-confirmed scalp lesions of 30 patients with chronic plaque psoriasis, 30 age- and sex-matched patients with seborrheic dermatitis and 30 healthy subjects. The morphology, mean density per mm(2) and mean diameter of capillary loops was measured. RESULTS: Scalp psoriasis exhibited homogeneously tortuous and dilated capillaries (bushy pattern), with a 73 +/- 17 mum (mean +/- standard deviation) diameter of capillary bushes. In contrast, scalp seborrheic dermatitis presented a multiform pattern, with mildly tortuous capillary loops and isolated dilated capillaries, but a substantial preservation of local microangioarchitecture. Mean diameter of capillary bush was significantly lower (27 +/- 4 microm; p < 0.001) and similar to that of the scalp of healthy subjects (21 +/- 5 microm). Capillary loop density was similar in patients with psoriasis (23 +/- 5/mm(2)) seborrheic dermatitis (24 +/- 2/mm(2)) and healthy scalp skin (24 +/- 3/mm(2)). CONCLUSION: VCP could be a useful noninvasive approach for differentiating between psoriasis and seborrheic dermatitis, especially when the scalp is the only affected site.     

Spotlight on Calcipotriene/Betamethasone Dipropionate in Psoriasis Vulgaris of the Trunk, Limbs, and Scalp

Calcipotriene (calcipotriol)/betamethasone dipropionate (calcipotriene 50 mg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D₃ analog and a corticosteroid indicated for the oncedaily, topical treatment of psoriasis vulgaris of the trunk, limbs, and scalp in adults. Both the ointment (Daivobet®;Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriene/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriene/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacologic properties. Calcipotriene/betamethasone dipropionate has low systemic absorption and displays local antiinflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriene/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4–8 weeks, was more effective than placebo, calcipotriene, or tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriene/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriene/betamethasone dipropionate for 52 weeks was more effective than calcipotriene alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriene for 48 weeks after 4 weeks of calcipotriene/betamethasone dipropionate or alternating between calcipotriene/betamethasone dipropionate and calcipotriene every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriene/betamethasone dipropionate also improved health-related quality of life. Calcipotriene/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriene/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriene or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriene/betamethasone dipropionate to be more cost effective than other topical therapies. Thus, calcipotriene/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs, and scalp.     

Efficacy of the pulsed dye laser in the treatment of localized recalcitrant plaque psoriasis: a comparative study

BACKGROUND: Localized chronic plaque psoriasis, resistant to local therapy, may be very hard to treat. The treatment of these lesions with a pulsed dye laser (PDL) has been described before, but a comparative study between the PDL and a potent topical treatment has never been performed. OBJECTIVES: To compare the efficacy of the PDL in the treatment of localized, recalcitrant plaque psoriasis with a potent topical therapy, using calcipotriol/betamethasone dipropionate (Dovobet) as an active comparator. METHODS: Eight patients with psoriasis were treated with both PDL (585 nm) and calcipotriol/betamethasone dipropionate in an open, intrapatient, left-right comparison. A plaque severity score (sum score) and photographs were used to document the course of therapy. Patients reported pain on a visual analogue scale. RESULTS: Both treatments were well tolerated, although one patient left the study due to post-PDL treatment pain. A significant difference in the sum score 12 weeks after treatment was seen in favour of the PDL (62% vs. 19% reduction; P<0.05). Scores for erythema declined significantly at week 12 in both the PDL and the calcipotriol/betamethasone dipropionate group (P<0.001). Induration and desquamation scores were significantly reduced at week 12 in the PDL group, without a statistically significant reduction in calcipotriol/betamethasone-treated lesions. The pain scores declined with progressive PDL treatments, although not statistically significantly. CONCLUSIONS: PDL treatment might be considered for the treatment of localized, recalcitrant plaque psoriasis, when other topical therapies have failed.     

Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized,double-blind,vehicle-controlled clinical trial

BACKGROUND: Calcipotriol and betamethasone dipropionate are both widely used, effective treatments for psoriasis. Vitamin D analogues and topical corticosteroids have different mechanisms of action in the treatment of psoriasis. A new vehicle has been developed in order to contain both calcipotriol (50 micro g g-1) and betamethasone dipropionate (0.5 mg g-1) in an ointment form. By using calcipotriol and a corticosteroid together, greater efficacy may be achieved than by using either compound alone. OBJECTIVES: The present study was conducted in order to compare the clinical efficacy and safety of the combined ointment formulation used once daily with the vehicle ointment used twice daily, calcipotriol ointment used twice daily and the combined formulation used twice daily in psoriasis vulgaris. METHODS: This was an international, multicentre, prospective, randomized, double-blind, vehicle-controlled, parallel group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Patients were randomized to one of four treatment groups: combined formulation once daily, combined formulation twice daily, calcipotriol twice daily or vehicle twice daily. Efficacy and safety were assessed. RESULTS: There was no statistically significant difference in the mean percentage change in the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment between the two combined formulation groups, but the difference in PASI reduction was significantly higher in the combined formulation groups (68.6% once daily, 73.8% twice daily) than in both the twice daily calcipotriol group (58.8%) and the vehicle group (26.6%). Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group. The proportion of patients with lesional/perilesional adverse reactions was less in the combined formulation groups and vehicle group than in the calcipotriol group (9.9% combined formulation once daily, 10.6% combined formulation twice daily, 19.8% calcipotriol, 12.5% vehicle). CONCLUSIONS: No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.     

The impact of a two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial

BACKGROUND: Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL). OBJECTIVES: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design. METHODS: The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. RESULTS: The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS. CONCLUSIONS: The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.     

Fixed-Dose Combination Therapy for Psoriasis

Fixed-dose combination therapy offers stable products containing two or more medications with different mechanisms of action and safety profiles. It is also convenient for patients since only one product rather than two or more needs to be applied. Topical corticosteroids are often the mainstay of therapy in psoriasis. Diprosalic and Nerisalic contain a topical corticosteroid (betamethasone dipropionate and diflucortolone, respectively) and salicylic acid. A left/right study showed that both products have comparable efficacy. It has also been shown that betamethasone dipropionate + salicylic acid ointment has similar efficacy to clobetasol and calcipotriene (calcipotriol) ointments. Betamethasone dipropionate + salicylic acid lotion has similar efficacy to clobetasol lotion. Faster improvement of scaling, itching, and redness was noted with betamethasone dipropionate + salicylic acid lotion compared with betamethasone dipropionate alone. Dovobet (Daivobet) ointment is a fixed-dose combination product containing betamethasone dipropionate and calcipotriene. Clinical studies have shown that it has greater efficacy and a faster speed of onset than the individual components or tacalcitol. Once daily and twice daily treatments have similar efficacy. Psoriasis Area and Severity Index reductions of approximately 40% after 1 week and 70% after 4 weeks of therapy were consistently noted in six large international studies involving >6000 patients. Betamethasone dipropionate + calcipotriene treatment is associated with approximately 75% less adverse cutaneous events as compared with tacalcitol, 50% less compared with calcipotriene, and a similar number as treatment with betamethasone dipropionate.     

Treatment of scalp psoriasis: review of the evidence and Delphi consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology

Scalp lesions are common in psoriasis and difficult to treat. Scientific evidence on the topic is scant and fragmentary, especially with respect to long-term treatment. This consensus statement is based on a critical assessment of the results of a MEDLINE search for clinical trials of the efficacy and safety of therapies used to treat scalp psoriasis. The recommendations were developed by an expert panel using the Delphi process to reach a consensus and then ratified by the members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology. The recommended induction therapy for scalp psoriasis is either a topical corticosteroid or a topical treatment combining calcipotriol and betamethasone. The choice of an appropriate vehicle is crucial in improving effectiveness and patient adherence to treatment. The only formulations that have been studied in the long-term treatment of scalp psoriasis are a combination of calcipotriol and betamethasone in gel and calcipotriol alone in solution.     

Calcipotriol ointment in nail psoriasis: a controlled double-blind comparison with betamethasone dipropionate and salicylic acid

This double-blind randomized study was designed to compare the efficacy and safety of calcipotriol ointment (50 μg/g) with betamethasone dipropionate (64 mg/g) and salicylic acid (0.03 g/g) ointment in the treatment of nail bed psoriasis. Fifty-eight patients applied the given drug to the affected nails twice a day for 3–5 months, depending on clinical response. Efficacy was assessed monthly on the basis of nail thickness, measured in millimetres. Photographs of the treated nails were taken at baseline, and after 3 and 5 months. Tolerability was assessed at 3 and 5 months. In patients with fingernail psoriasis, after 3 months of treatment subungual hyperkeratosis was reduced from 2.3 ± 0.1 mm (mean ± SEM) to 1.5 ± 0.1 mm (?26.5%) in the calcipotriol group and from 2.3 ± 0.1 mm to 1.6 ± 0.1 mm (?30.4%) in the betamethasone dipropionate and salicylic acid group [not significant (NS) between treatments, analysis of variance ( ANOVA )]. After 5 months, responders showed a 49.2% reduction in hyperkeratosis in the calcipotriol group (from 2.8 ± 0.1 mm to 1.4 ± 0.2 mm) and 51.7% (from 2.1 ± 0.1 mm to 1.0 ± 0.1 mm) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA ). In patients with toenail psoriasis, after 3 months of treatment there was an overall reduction in hyperkeratosis from 2.6 ± 0.1 mm to 2.1 ± 0.1 mm (?20.1%) in the calcipotriol group and from 3.0 ± 0.1 mm to 2.3 ± 0.1 mm (?22.9%) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA ). By the end of the fifth month there was a 40.7% reduction in hyperkeratosis in the calcipotriol group (from 2.1 ± 0.1 mm to 1.2 ± 0.1 mm) and 51.9% in the betamethasone dipropionate and salicylic acid group (from 2.7 ± 0.1 mm to 1.3 ± 0.1 mm; P < 0.0001 from baseline, NS between treatments, ANOVA ). The results of the study show that calcipotriol is as effective as a combination of a topical steroid with salicylic acid in the treatment of nail psoriasis and represents a safe alternative in the topical treatment of nail psoriasis.     

Treatment of psoriasis with a new combination of calcipotriol and betamethasone dipropionate: a flow cytometric study

BACKGROUND: Calcipotriol and corticosteroids are established topical antipsoriatics. Previous studies have shown that combined therapy with calcipotriol and betamethasone dipropionate was more effective than monotherapy. In the present study, a recently developed combination product of calcipotriol and betamethasone dipropionate was compared with both monotherapies and the vehicle. METHODS: Twenty-five psoriatic patients were treated twice daily with the combination product, monotherapy or vehicle during 4 weeks. Skin biopsies, taken before and after treatment, were analysed using a multi-parameter flow cytometric method. Parameters of inflammation (vimentin-positive cells), normal differentiation (keratin-10-positive cells) and proliferation (cells in SG(2)M-phase) were assessed. RESULTS: Flow cytometric analysis showed that the combination product turned out to be more effective in reducing inflammation compared with the other treatments. Restoration of normal differentiation was more advanced in patients treated with the combination product or betamethasone dipropionate compared to the vehicle. The highest number of normally differentiated cells was seen after use of the combination product. All treatments, except for the vehicle, decreased hyperproliferation. CONCLUSIONS This study shows that the combination product is a valuable new approach to the treatment of psoriasis.     

A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris

BACKGROUND: Topical corticosteroids and calcipotriol have been used separately for many years to treat psoriasis. A new combination ointment has been formulated, which contains both calcipotriol and the corticosteroid betamethasone dipropionate. OBJECTIVE: To compare the combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle in patients with psoriasis vulgaris. METHODS: 1,603 patients were randomised to one of the 4 double-blind treatments used once daily for 4 weeks. RESULTS: The mean percentage change in the PASI at the end of treatment was -71.3 (combination), -57.2 (betamethasone), -46.1 (calcipotriol) and -22.7 (vehicle). The mean difference of combination minus betamethasone was -14.2 (95% CI: -17.6 to -10.8, p < 0.001), of combination minus calcipotriol -25.3 (95% CI: -28.7 to -21.9, p < 0.001) and of combination minus vehicle -48.3 (95% CI: -53.2 to -43.4, p < 0.001). 6.0% of patients (combination) reported local adverse reactions compared to 4.9% (betamethasone), 11.4% (calcipotriol) and 13.6% (vehicle). CONCLUSION: Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone.     

Engaging psoriasis patients in adherence and outcomes to topical treatments: A summary from the Symposium ‘Tailoring topical psoriasis treatments to patients' needs and expectations’ of the 30th EADV Congress 2021

This article is based on a presentation given by authors at the Satellite Symposium titled ‘Tailoring topical psoriasis treatments to patients' needs and expectations’ held during the 30^th European Academy of Dermatology and Venereology Congress. During this session, the factors affecting adherence and outcomes to topical treatments were presented, with a particular focus on the patients' point of view. Psoriasis is not just a skin condition. Psoriasis can cause negative psychosocial effects, such as depression and anxiety. The risk of suicidality in patients with psoriasis is higher than in the background population. Psychosocial comorbidities can be prevented by patient involvement in psoriasis management and need to be treated in a multidisciplinary manner. Adherence may be the largest barrier to treatment success with topical therapies. Improvement in several areas of disease management may lead to benefits in treatment adherence and hence clinical benefit. There are several treatment-related factors for non-adherence, such as patient dissatisfaction, side effects, treatment regimen or the drug vehicle. Delivering comprehensive treatment information to the patient will help develop realistic objectives and expectations. Patients need to be involved in the selection of treatment strategies, as psoriasis patients have various preferences for their use of topical treatments. A shared decision-making with the patient has been shown to improve medication adherence and treatment success. Prescribing therapy in line with a patient preference for treatment vehicle and improving the communication between healthcare professionals and patients may be key factors to maximize adherence. The calcipotriol (CAL) and betamethasone dipropionate (BDP) cream, a novel formulation of the CAL/BDP fixed-dose combination based on Poly-Aphron Dispersion (PAD) Technology, is a topical treatment of mild-to-moderate plaque psoriasis, including scalp psoriasis, that has high cosmetic acceptance and overall treatment satisfaction.     

Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis

BACKGROUND: Calcipotriene and betamethasone dipropionate are topical treatments for psoriasis vulgaris. Their mode of action is different. Improved risk/benefit may result with concomitant use of the two compounds together. A new vehicle has been created with the objective of obtaining optimal stability of both calcipotriene and betamethasone dipropionate in the combination product. OBJECTIVE: We compared the clinical efficacy of a fixed combination of calcipotriene and betamethasone dipropionate in a new vehicle to calcipotriene in the new vehicle, betamethasone in the new vehicle, and the new vehicle alone. METHODS: This was an international, multicenter, prospective, randomized, double-blind, parallel-group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. RESULTS: The mean percentage reduction in PASI from baseline to end of treatment was 73.2% in the combination group (n = 301), 48.8% in the calcipotriene group (n = 308), 63.1% in the betamethasone dipropionate group (n = 312) and 28.8% in the new vehicle group (n = 107), (P < .001). The mean percentage reduction in PASI during the first week was 48.1%, 28.4%, 41.4%, and 21.5%, respectively (P < .001). CONCLUSION: A combination product of calcipotriene 50 microg/g and betamethasone dipropionate 0.5 mg/g in the new vehicle shows superior efficacy with a more rapid onset of action than the new vehicle containing either constituent alone in the treatment of psoriasis vulgaris.     

Response of cutaneous microcirculation to treatment with mometasone furoate in patients with psoriasis

Background. In patients with psoriasis, videocapillaroscopy has been used to visualize the typical modifications in the microcirculatory architecture. Aim. To evaluate the modifications of the superficial capillary bed in a psoriatic plaque and healthy perilesional skin during treatment with a topical steroid. Methods. In total, 24 patients affected with psoriasis vulgaris were enrolled. Each patient was instructed to apply mometasone furoate cream 0.1% once daily to a selected psoriatic lesion for 12 weeks. At baseline (T0) and after 4 (T1), 8 (T2) and 12 (T3) weeks, clinical and capillaroscopic examination was made of the psoriatic plaque and the surrounding skin. Results. At the end of the study, the diameters of dilated and convoluted capillaries in the psoriatic plaque were significantly reduced (baseline, 69.2 μm; after 12 weeks, 29.3 μm; P < 0.0001) in all subjects. A marked clinical improvement was also noted (plaque score: baseline, 7.4; after 12 weeks, 0.5; P < 0.0001). The perilesional skin also showed improvement in capillaroscopic alterations, even if the drug had not been applied to those areas. Of the 24 patients, 12 were clinically healed at the end of the treatment period, although the capillaroscopic picture returned to normal in only 2 of them. Conclusions. Mometasone furoate cream proved to be effective in reducing the clinical and capillaroscopic alterations of the psoriatic plaque, but there was no association between clinical improvement and microcirculatory alterations noted. The action of mometasone furoate action on the microcirculation was not limited only to the area of application, but also extended to the surrounding areas.     

Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial

Background Current topical therapies for scalp psoriasis are difficult or unpleasant to apply, resulting in decreased adherence and efficacy. Objectives To compare the efficacy and safety of once‐daily treatment with a combination of calcipotriol 50 μg g^?1 plus betamethasone 0·5 mg g^?1 (as dipropionate) (Xamiol^®; LEO Pharma A/S, Ballerup, Denmark) and twice‐daily calcipotriol 50 μg mL^?1 scalp solution in patients with scalp psoriasis. Methods This 8‐week, multicentre, randomized, investigator‐blind, parallel‐group study compared two‐compound calcipotriol/betamethasone scalp formulation with calcipotriol scalp solution in patients with moderately severe scalp psoriasis. Primary efficacy outcome was the proportion of patients who achieved ‘clear’ or ‘minimal’ disease severity according to investigator’s global assessment of disease severity at week 8. Secondary efficacy outcomes and adverse events were also evaluated. Relapse and rebound were assessed in an 8‐week, post‐treatment observation phase. Results In total, 207 patients received the two‐compound scalp formulation and 105 patients received calcipotriol scalp solution. The proportion of patients with ‘clear’ or ‘minimal’ disease at week 8 was significantly greater in the two‐compound scalp formulation group (68·6%) than in the calcipotriol scalp solution group (31·4%; P < 0·001). Improvement was more rapid with the two‐compound scalp formulation than with calcipotriol scalp solution. Further evidence of the superiority of the two‐compound scalp formulation over the scalp solution was demonstrated through greater improvements in clinical signs and fewer adverse events. Conclusions A once‐daily combination of calcipotriol plus betamethasone dipropionate was significantly more effective and better tolerated than twice‐daily calcipotriol scalp solution in the treatment of scalp psoriasis.     

Actualización del tratamiento tópico en psoriasis: aportación de la combinación de calcipotriol y dipropionato de betametasona en espuma

Topical agents are the first-line treatment for mild and moderate psoriasis, but factors such as frequency of administration, organoleptic properties, and the limited short term results can reduce treatment adherence and effectiveness.Innovations in topical treatments are linked not only to the discovery of new molecules, but also to the reformulation of existing active ingredients based on improvements to administration, organoleptic properties, bioavailability, and ease of use. Calcipotriol and betamethasone dipropionate aerosol foam is a new formulation in which the active ingredients are dissolved in a mixture of volatile propellants that evaporate quickly, leaving a supersaturated solution of calcipotriol and betamethasone dipropionate that enhances penetration into the epidermis.In this article, we take a look at the new calcipotriol and betamethasone dipropionate aerosol formulation and briefly review the main evidence supporting the use of topical treatments for psoriasis.