A Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Calcipotriene Foam, 0.005%, vs Vehicle Foam in the Treatment of Plaque-type Psoriasis of the Scalp.
ABSTRACT Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.
To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P <.001); a significant difference between groups was also observed at weeks 2 ( P =.041) and 4 ( P <.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P =.544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling ( P =.019) and plaque thickness ( P =.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema. Limitations: An 8-week study provides limited safety and efficacy data.
Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.
J Drugs Dermatol. 2013;12(3):300-306.
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ABSTRACT: Psoriasis affects 2-4% of the population worldwide and its treatment is currently far from satisfactory. Calcipotriol and Portulaca oleracea have been reported to exhibit the capacity to inhibit inflammation in psoriatic patients and improve their clinical condition. However, the efficacy of a combination regimen of these two components remains unknown. The aim of the present study was to explore the therapeutic efficacy of P. oleracea extract combined with calcipotriol on plaque psoriasis and its potential mechanism. Eleven patients with plaque psoriasis were treated with humectant containing the active ingredients of P. oleracea extract, with or without 0.005% calcipotriol ointment in a right-left bilateral lesion self-control study. Differences were evaluated by investigation of the clinical efficacy, adverse effects, skin barrier function, histological structure, expression and proliferation of keratinocytes, differentiation markers (cytokeratin 10, filaggrin and loricrin), inflammatory factors [tumor necrosis factor (TNF)-α and interleukin (IL)-8], as well as the status of the nuclear factor κB (NF-κB) pathway. The combination of P. oleracea and calcipotriol was revealed to decrease adverse effects, reduce transepidermal water loss, potently reverse keratinocyte differentiation dysfunction, and inhibit the expression of TNF-α and IL-8 and the phosphorylation of the NF-κB inhibitor IκBα. This treatment is therefore anticipated to be suitable for use as a novel adjuvant therapy for psoriatic patients.Experimental and therapeutic medicine 02/2015; 9(2):303-310. DOI:10.3892/etm.2014.2116 · 0.94 Impact Factor
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ABSTRACT: Introduction: Psoriasis is a common immune-mediated disorder that in 70% of cases appears in mild or mild-to-moderate form. Psoriasis is usually treated with topical medications and/or phototherapy with variable efficacy in controlling the disease. Areas covered: For the past three decades, research has been focused on systemic agents for the treatment of moderate-to-severe psoriasis, particularly with the introduction of biologic agents or 'small molecules'. In parallel, novel advances in topical antipsoriatic agents have been made, experiencing a 'new era', with the development of new formulations and the identification of new therapeutic targets. These agents, having a different spectrum of action from traditional agents, are actually being tested in pre-marketing clinical trials and they may potentially represent promising treatment options that could enlarge the therapeutic armamentarium for the treatment of psoriasis. Expert opinion: Future antipsoriatic topical agents show new modality of action in blocking the pathogenic process leading to psoriatic plaque formation.Expert Opinion on Pharmacotherapy 01/2014; DOI:10.1517/14656566.2014.875159 · 3.09 Impact Factor