卡泊三醇搽剂联合矿泉浴治疗头部银屑病疗效观察

目的探讨卡泊三醇搽剂联合矿泉浴治疗头部银屑病的临床疗效。方法治疗组43例患者每日矿泉浴1次,卡泊三醇搽剂外用早晚各1次;对照组43例患者仅外用卡泊三醇搽剂,早晚各1次。两组卡泊三醇每周用量不超过60mL,疗程均为6周。结果治疗组和对照组有效率分别为93.02%和76.74%,差异有统计学意义(P<0.05)。结论卡泊三醇搽剂联合矿泉浴治疗头部银屑病用药方便,安全有效。     

钙泊三醇倍他米松软膏与卡泊三醇软膏联合NB-UVB治疗稳定期寻常性银屑病疗效比较

目的观察钙泊三醇倍他米松软膏和卡泊三醇软膏分别联合窄谱中波紫外线(NB-UVB)照射治疗寻常性银屑病的疗效与安全性。方法将入选的60例患者随机分为2组,各30例。治疗组每晚用钙泊三醇倍他米松软膏外搽皮损1次,对照组每日早、晚分别予卡泊三醇软膏外搽皮损1次,且两组同时予NB-UVB照射治疗,3次/周。两组患者的疗程均为4周。分别于治疗过程中每周观察1次疗效。结果治疗2周时,治疗组有效率(33.33%)高于对照组(10.00%),差异有统计学意义(P<0.05)。治疗4周时,治疗组有效率和对照组差异不显著(P>0.05)。主要不良反应为瘙痒和毛囊炎。结论钙泊三醇倍他米松软膏或卡泊三醇软膏联合NB-UVB治疗寻常性银屑病均安全有效,但钙泊三醇倍他米松软膏起效快于卡泊三醇软膏。     

卡泊三醇联合氟轻松序贯治疗头皮银屑病疗效观察

目的:评价卡泊三醇联合氟轻松治疗头皮银屑病的疗效及安全性。方法:70例患者随机分为序贯治疗组和对照组。序贯治疗组:外用卡泊三醇搽剂和氟轻松溶液;对照组外用卡泊三醇搽剂。治疗后第2、4、8周末进行疗效评价。结果:治疗2、4、8周后序贯治疗组有效率(48.57%、71.43%和91.43%)均明显高于对照组(25.71%、40.00%和60.00%),组间差异均有统计学意义(P0.05)。结论:卡泊三醇搽剂联合氟轻松溶液序贯疗法治疗头皮银屑病起效快、疗效好且不良反应小。     

外用卡泊三醇倍他米松凝胶治疗头皮银屑病临床研究

目的观察卡泊三醇倍他米松凝胶治疗头皮银屑病的临床疗效。方法将2016年7月-2017年10月于我院皮肤科门诊就诊的97例头皮银屑病患者随机分为3组。治疗组34例,每晨1次卡泊三醇倍他米松凝胶外搽头皮;对照1组,31例,每晨1次卡泊三醇搽剂外搽头皮;对照2组,32例,每晨1次倍他米松搽剂外搽头皮。疗程4周,分别在治疗前和治疗2周、4周时对头皮银屑病患者银屑病皮损面积和严重程度指数(PASI)评分和疗效评估。结果治疗第2周时,治疗组患者的PASI评分为(9.12±2.54)分,低于对照1组的(12.26±2.23)分及对照2组的(10.11±2.02)分,差异有统计学意义(P<0.05);治疗第4周时,治疗组患者的PASI评分(4.02±2.78)分,明显低于对照1组的(8.26±2.23)分及对照2组的(6.11±2.02)分,差异有统计学意义(P<0.05);治疗第2周、4周时,治疗组患者的治疗有效率分别为38.24%、82.35%,均高于对照1组的25.81%、54.84%及对照2组的34.38%、65.63%,但仅治疗4周时的有效率比较差异有统计学意义(P<0.05)。结论外用卡泊三醇倍他米松凝胶治疗头皮银屑病疗效确切,使用方便,不良反应小,可广泛应用于临床。     

钙泊三醇头皮搽剂治疗头部银屑病

钙泊三醇（ｃａｌｃｉｐｏｔｒｉｏｌ）是一种维生素Ｄ３衍生物,具有抑制角质形成细胞增殖和促进角质形成细胞分化成熟及抑制炎症反应等药理作用。头皮是银屑病的好发部位,但因头部毛发多,软膏制剂使用不方便。为此,丹麦利奥制药公司开发出钙泊三醇头皮搽剂,并获美国ＦＤＡ批准。根据我国卫生部药政管理局批件,由北京医科大学第一医院皮肤科和中国医学科学院北京协和医院皮肤科于１９９８年３月至１９９８年６月对钙泊三醇头皮搽剂治疗头部银屑病的有效性和安全性进行了多中心、随机、开放临床验证,现总结如下。一、病例与方法病例选择:入选…     

308nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病疗效评价

目的：评价308 nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病的临床疗效.方法：将93例稳定期斑块状银屑病随机分为3组,治疗组（33例） 予308 nm准分子激光照射,每周2次联合外搽卡泊三醇软膏,每日2次;对照1组（30例）外搽卡泊三醇软膏;对照2组（30例）,予308 nm准分子激光照射,方法同治疗组,2个月后判断疗效.结果：治疗组、对照1组和对照2组的有效率分别为90.91%、73.33%、63.33%.3组间疗效比较差异有统计学意义（均P〈0.05）.结论：308 nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病能更好地提高疗效.     

钙泊三醇倍他米松软膏联合卡泊三醇软膏序贯治疗寻常型银屑病疗效评价

目的：评价钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病的临床疗效。方法：30例银屑病患者全身左右侧皮损随机分为治疗组或对照组。治疗组外用钙泊三醇倍他米松软膏和卡泊三醇软膏;对照组外用卡泊三醇软膏。治疗第2、4、8周末进行疗效评价。结果：治疗2、4、8周后治疗组有效率（53.33%、70%和86.67%）均明显高于对照组（30%、46.67%和66.67%）,组间差异均有统计学意义（P〈0.05）。结论：钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病疗效较单独使用卡泊三醇好。     

钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病疗效观察

目的观察钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病的临床疗效及不良反应。方法将93例寻常性斑块状银屑病患者随机分为试验组和对照组,均外用钙泊三醇倍他米松软膏每日1次;试验组同时给予中药方剂洗浴每日1次,对照组使用婴儿沐浴液洗浴每日1次,两组均4周为1个疗程,分别于2、4周时观察疗效。结果治疗结束后,试验组有效率为86.96%,对照组有效率为70.21%,两组比较差异有统计学意义(χ2=3.86,P0.05)。两组患者均无严重不良反应。结论钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病疗效好,能很快缓解皮损症状,是一种安全有效的治疗方法。     

达力士搽剂治疗头部银屑病35例疗效观察

银屑病是皮肤科的常见病。丹麦利奥公司生产的达力士软膏,为非皮质类固醇药物,广泛用于临床,外搽治疗银屑病疗效良好。头部是银屑病好发部位,且较顽固不易治疗,软膏制剂使用不方便。因此,丹麦利奥公司开发生产出达力士头皮搽剂。达力士搽剂内含卡泊三醇(原名钙泊三醇,浓度50μｇ/ｍＬ),具有抑制角质形成细胞增殖、促进角质形成细胞成熟分化和抑制皮损局部炎症反应的作用。我们中国医学科学院皮肤病研究所、江苏省人民医院皮肤科、南京市鼓楼医院皮肤科、南京铁道医学院附院皮肤科等单位用此搽剂治疗了35例头部银屑病患者,获得较好疗效,现将…     

钙泊三醇头皮搽剂治疗头部银屑病疗效观察

钙泊三醇是一种安全有效的外用治疗银屑病的新药。我科于１９９８年４月～７月,用丹麦利奥（Ｌｅｏ）制药厂生产的钙泊三醇（达力士）头皮搽剂治疗３２例头部银屑病,取得了较好疗效,现将结果总结如下。１病例选择１１入选标准：男女患者均可入选,年龄１８～６５岁;...     

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.     

0.1%他克莫司软膏治疗头面部银屑病临床疗效观察

目的:观察外用0.1%他克莫司软膏治疗头面部斑块状银屑病的临床疗效及安全性.方法:将40例头面部斑块状银屑病患者随机分为试验组和对照组,每组各20例.试验组外用0.1%他克莫司软膏,对照组外用5%松馏油软膏,每日2次,疗程均为8周.于治疗前及治疗后2、4、6、8周各随访1次.记录皮损变化及不良反应.结果:试验组治愈率为85%,对照组为55%(P<0.05);有效率分别为95%和60%(P<0.05);药物不良反应发生率分别为5%(1/20例)和15%(3/20例).结论:他克莫司软膏外用治疗头面部斑块状银屑病安全有效.     

Long-term treatment of psoriasis with calcipotriol scalp solution and cream

The efficacy and safety of long-term concurrent twice-daily treatment of scalp and body psoriasis with calcipotriol scalp solution (50 mcg/ml) and calcipotriol cream (50 mcg/g) were evaluated in a prospective, multi-centre, open-label, non-controlled evaluation over 52 weeks in 202 patients. Safety and efficacy as measured by total sign score (scalp psoriasis), modified PASI (body psoriasis) and patient self-assessment were assessed at week 2, 6 and 10 and thereafter every six weeks. By week 28, mean total sign score for scalp psoriasis had reduced from 5.9 to 2.5 (p<0.001). No further reduction was seen. By week 34, mean PASI for body psoriasis had reduced from 6.8 to 2.6 (p<0.001). No further reduction was seen. At week 52, the percentage of patients assessing their psoriasis as moderate or severe had decreased from 72 to 21% for scalp psoriasis and from 62 to 19% for body psoriasis. Facial irritation was the most frequent adverse event (91/276 events) with the highest incidence occurring at week 2 and few new reports at subsequent visits. There were no significant changes in mean serum calcium, parathormone or urinary calcium/creatinine ratio. Combined treatment with calcipotriol scalp solution and cream was effective and safe for long-term treatment of scalp and body psoriasis.     

Safety and efficacy of combined high-dose treatment with calcipotriol ointment and solution in patients with psoriasis

Background: In the vast majority of psoriatic patients, psoriatic lesions are localised on the body as well as on the scalp. Therefore, safety data on the combined use of calcipotriol in lotion and calcipotriol in ointment are needed. Objective: This study investigated the effect of high-dose treatment with a combination of calcipotriol ointment and scalp solution on calcium metabolism, indices of bone turnover and PASI in patients with extensive psoriasis. Methods: Following a 2-week wash-out period, 88 patients were randomised to 4 weeks of treatment with either calcipotriol ointment/scalp solution (80-100 g/week and 30-50 ml/week, respectively; n = 41) or with a dithranol/tar regimen (n = 47). Patients were seen at weeks 1, 2 and 4 during treatment and 1 week following cessation of treatment. Results: No significant differences at the end of treatment were found between the 2 groups with respect to 24-hour urinary excretion of calcium (expressed as calcium/creatinine ratio), phosphate or pyridinoline, serum concentrations of calcium (albumin corrected), creatinine, phosphate, parathyroid hormone, 25-hydroxyvitamin D(3), 1,25-dihydroxyvitamin D(3), osteocalcin, alkaline phosphatase (total and bone-specific iso-enzymes) or 1-collagen telopeptide. At the end of treatment, the psoriasis area and severity index had decreased by 57.4% in the calcipotriol group and by 36.1% in the dithranol/tar group (p = 0.004). Investigators' and patients' assessments of overall efficacy also favoured treatment with calcipotriol (p < 0.001). Conclusion: The combined use of calcipotriol ointment/scalp solution did not affect the indices of calcium metabolism or bone turnover and was significantly more effective than dithranol/tar in reducing disease severity and extent in patients with extensive psoriasis.     

Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis

The treatment of psoriasis requires good compliance, efficacy and low toxicity because of its long-term course and wide distribution. The aim of the study was to compare the efficacy of a once daily application of calcipotriol alone or calcipotriol and a superpotent steroid in a premixed form in patients with psoriasis. The monotherapy group of 32 patients with stable plaque psoriasis received 0.005% calcipotriol alone once daily. The combination group of 29 patients was treated once per day with 0.004% calcipotriol/0.01% clobetasol propionate as a premixed ointment. Eruption score of truncal involvement was evaluated. The combination regimen was more efficacious than the monotherapy as evidenced by (1) more patients with at least 50% reduction in the eruption score after 2 weeks, (2) lower eruption score after 6 weeks and later, and (3) less adverse effects. The combined once-per-day application of 0.004% calcipotriol/0.01% clobetasol propionate as a premixed ointment is a promising regimen for psoriasis.     

Efficacy of treatment with calcipotriol/betamethasone dipropionate followed by calcipotriol alone compared with tacalcitol for the treatment of psoriasis vulgaris: a randomised, double-blind trial

BACKGROUND: A two-compound product containing calcipotriol 50 microg/g and betamethasone dipropionate 0.5 mg/g (Daivobet, Dovobet) has been demonstrated to be an effective, once daily, treatment for psoriasis vulgaris. OBJECTIVE: To compare the efficacy and safety of treatment with the two-compound product for 4 weeks followed by calcipotriol for 4 weeks, with that of tacalcitol for 8 weeks in patients with stable psoriasis vulgaris. METHODS: 501 patients were randomised to double-blind treatment with the two-compound product followed by calcipotriol 50 microg/g once daily, or to tacalcitol 4 microg/g once daily. RESULTS: Treatment with the two-compound product/calcipotriol was significantly more effective than tacalcitol in terms of mean percentage PASI reduction (65.0 vs. 33.3% at week 4 and 59.0 vs. 38.4% at week 8; p < 0.001 for both). CONCLUSION: A treatment regimen comprising calcipotriol/betamethasone ointment (Daivobet) for 4 weeks followed by calcipotriol for 4 weeks is superior to tacalcitol ointment for 8 weeks in patients with psoriasis vulgaris.     

Calcipotriol Ointment

Abstract

Calcipotriol, a vitamin D₃ analog, acts not only to inhibit cell proliferation and enhance cell differentiation in the skin of patients with psoriasis, but also appears to have effects on immunologic markers that are thought to play a role in the etiology of the disease. In several well designed, short term studies in adults, calcipotriol ointment 50 μg/g twice daily provided similar or superior efficacy to several other antipsoriatic agents in adult patients with mild to moderate psoriasis. In patients with nonscalp psoriasis, the drug provided superior efficacy to twice daily placebo (vehicle ointment), twice daily fluocinonide 500 μg/g, once daily tacalcitol 4 μg/g and twice daily coal tar 5% plus allantoin 2% and hydrocortisone 0.5%. Furthermore, calcipotriol therapy generally provided superior efficacy to twice daily betamethasone valerate 1 to 1.2 mg/g or once daily dithranol 1 to 20 mg/g, and similar efficacy to twice daily betamethasone dipropionate plus salicylic acid or once daily maxacalcitol 6 to 50 μg/g. Limited data indicated that calcipotriol ointment 50 μg/g also improved overall disease severity in children. In combination with other antipsoriatic agents [acitretin, cyclosporine, betamethasone valerate, halobetasol (ulobetasol)], ultraviolet B or psoralen ultraviolet A (PUVA) phototherapy, calcipotriol ointment 50 μg/g twice daily improved the beneficial effects of these drugs on overall disease severity in adult patients with moderate to severe psoriasis. Furthermore, in separate trials, calcipotriol combination therapy reduced the dosage of acitretin required to achieve clearance of psoriasis and the duration of PUVA and dosage of UVA phototherapy, potentially improving the benefit/risk ratio for these other antipsoriatic treatments. Calcipotriol was generally well tolerated in short and long term studies in adult patients, with the majority of adverse events being mild to moderate in intensity and transient. The most common adverse events associated with calcipotriol therapy were dermatologic in nature and included lesional or perilesional irritations, face and scalp irritations, worsening of psoriasis and miscellaneous dermatologic events. Notably, there have been very few reports of patients developing hypercalcemia or hypercalciuria during calcipotriol therapy, with most occurring in patients who exceeded the recommended dosage of 100 g/week. Although data in children are limited, the drug was well tolerated with the nature and incidence of adverse effects similar to those observed in adult patients. Conclusions: Extensive clinical experience, along with several short and long term clinical trials, has shown calcipotriol ointment to be an effective and well tolerated topical agent in adult patients with psoriasis. In addition, calcipotriol ointment proved beneficial in combination with other topical, phototherapy or systemic antipsoriatic treatments, reducing the dosage and/or duration of some of these treatments and potentially improving their benefit/risk ratio. Calcipotriol ointment is valuable as a first- or second-line therapy option for the management of mild to moderate psoriasis and in combination with other antipsoriatic agents for more severe psoriasis.

Pharmacologic Properties

Calcipotriol inhibits cell proliferation and enhances cell differentiation in the skin of patients with psoriasis. These effects are mediated by binding of the drug to vitamin D receptors. Flow cytometric analysis of epidermal samples has shown significant decreases relative to placebo in numbers of proliferating basal keratinocytes in psoriatic skin treated with topical calcitriol. In addition, application of calcipotriol ointment 50 μg/g twice daily for up to 8 weeks has been shown to result in partial recovery of the stratum corneum, restoration of the stratum granulosum, and correction of intercellular spacing and number and structure of desmosomes. Application of calcipotriol ointment for 4 weeks has been associated with suppression of epidermal T cell and polymorphonuclear leucocyte accumulation in psoriatic lesions. The drug has also been shown to reduce numbers and activity of Langerhans cells, although these effects have not been shown consistently across studies and require further investigation. Other effects described include increased interleukin-10 and reduced interleukin- 8 expression, and normalization of cellular integrin distribution. Overall, application of up to 120 g/week of calcipotriol ointment 50 μg/g did not alter calcium utilization or bone turnover in pharmacodynamic studies in humans. Dosages of 100 to 300 g/week have, however, been associated with increased levels of calcium and reduced levels of parathyroid hormone (PTH) in serum, and increased urinary excretion of calcium. These effects have been attributed to increased intestinal absorption of calcium and subsequent suppression of secretion of PTH and endogenous calcitriol. Measurement of levels of radioactivity in blood, urine and feces after application of ointment containing ³H-calcipotriol has indicated systemic absorption of up to approximately 6% of applied drug in patients with psoriasis. Calcipotriol appears to be metabolized and cleared rapidly after absorption, with hepatic oxidation to 2 relatively inactive metabolites (MC1046 and MC1080) being the major route of elimination. Data obtained in rats showed elimination half-lives in blood collected up to 10 minutes after intravenous administration to be 4 and 14 minutes for calcipotriol and calcitriol, respectively. Corresponding total clearance values were 0.68 and 0.0055 L/h.

Clinical Efficacy

The short term clinical efficacy of calcipotriol ointment 50 μg/g twice daily has been evaluated in several reasonably sized (≥50 enrolled patients) comparative studies of ≤14 weeks duration in adult patients with psoriasis. In placebo (vehicle)-controlled studies, calcipotriol recipients experienced better reductions in overall disease severity (52 to 59% vs 16 to 35%), with a greater percentage of calcipotriol-treated patients achieving a ≥75% improvement in severity of psoriasis or complete clearance (responders) than placebo (59 to 74% vs 12 to 19%). Furthermore, topical calcipotriol ointment 50 μg/g twice daily provided superior efficacy to once daily tacalcitol 4 μg/g, twice daily fluocinonide 500 μg/g or twice daily coal tar 5% plus allantoin 2% and hydrocortisone 0.5% in patients with nonscalp psoriasis. In addition, calcipotriol recipients generally experienced superior beneficial effects on psoriasis severity to betamethasone valerate (1 to 1.2 mg/g twice daily) or once daily dithranol 1 to 20 mg/g recipients and similar efficacy to those receiving betamethasone dipropionate plus salicylic acid or once daily maxacalcitol 6 to 50 μg/g. Calcipotriol ointment also had significantly (p < 0.001) greater cosmetic acceptability than short-contact dithranol cream. Patient’s quality of life was significantly (p ≤ 0.02, both comparisons) improved from pretreatment levels with twice daily calcipotriol ointment 50 μg/g (assessed using Psoriasis Disease Index and Sickness Impact Profile instruments). Long term evaluations indicated that improvements in disease severity demonstrated with calcipotriol ointment therapy in the short term were maintained throughout the study period in several noncomparative trials of up to 1 year in duration in adult patients with psoriasis. At the end of the treatment period, 54 to 98% of calcipotriol recipients had shown a marked or ≥75% improvement in severity of psoriasis in these trials. Furthermore, in a randomized double-blind study, significantly (p < 0.05) more recipients of combination ‘pulse therapy’ consisting of calcipotriol ointment 50 μg/g (applied twice daily on week days) plus halobetasol ointment 500 μg/g (applied twice daily during the weekend) remained in remission throughout the 6-month study period than halobetasol recipients (using the same dosage plus placebo ointment twice daily during the week) [76 vs 40%]. Combining topical calcipotriol ointment (50 μg/g) with a topical corticosteroid, ultraviolet B (UVB) phototherapy, psoralen ultraviolet A (PUVA) phototherapy, or systemic (cyclosporine, acitretin) antipsoriatic agents improved the effects of the individual agents in reducing overall disease severity in short term studies of 2 to 12 weeks’ duration in adults. Overall psoriasis severity scores were reduced by 74 to 91% with calcipotriol-combination therapy compared with reductions of 35 to 83% in comparator agent monotherapy groups. Importantly, the addition of calcipotriol to acitretin or PUVA phototherapy reduced the dosage of these antipsoriatic therapies required and duration of UVA phototherapy. Data on the therapeutic efficacy of topical calcipotriol ointment in children are limited. After 8 weeks’ therapy, there was no significant difference in the reduction in overall disease severity between twice daily calcipotriol ointment 50 μg/g and placebo (ointment vehicle; 52 vs 37% reduction) in children aged 2 to 14 years. Nevertheless, subscale scores for erythema and scaling showed significantly (p < 0.05, both comparisons) greater reductions in calcipotriol than placebo recipients. In addition, significantly (p < 0.05) more calcipotriol recipients had shown a marked improvement or clearance of psoriasis than placebo (60 vs 44%). Topical calcipotriol ointment 50 μg/g twice daily also proved effective in reducing disease severity in a long term noncomparative study in 12 children aged 8 to 15 years. The mean overall Psoriasis Area and Severity Index score was reduced by 65% following calcipotriol treatment for a mean duration of 40 weeks.

Tolerability

In short term studies (6 to 8 weeks’ duration) the most common dermatologic adverse events associated with calcipotriol ointment 50 μg/g twice daily were lesional and perilesional irritation (12 to 20.1% of patients), face and scalp irritations (2 to 4.2%), worsening of psoriasis (2.9 to 3.9%) and miscellaneous adverse events (2.2 to 10.9%). The incidence of nondermatologic adverse events (e.g. arthralgias, bronchospasm, fatigue, flu-like symptoms, headache and nausea/vomiting) in these large trials was 1.2 to 2.9% of patients, with the overall incidence of adverse events ranging from 12 to 35.1% of patients. Symptoms were generally transient and mild to moderate in intensity. Zero to 10.2% of patients withdrew because of adverse events attributable to calcipotriol ointment treatment. The nature of adverse events occurring in long term studies was similar to those observed with short term studies, although the overall incidence of adverse events declined over time. Serious adverse events associated with calcipotriol therapy were rare. Calcipotriol ointment 50 μg/g twice daily was better tolerated than dithranol, but was associated with a significantly (p < 0.001) higher incidence of lesional and perilesional irritation than betamethasone valerate treatment. Although no significant differences in the nature and incidence of adverse events were reported between calcipotriol ointment or tacalcitol treatment in patients with nonscalp psoriasis, in those with scalp psoriasis there was a trend to a higher incidence of facial irritations with calcipotriol than tacalcitol. In general clinical practice, there have been very few reports of patients developing hypercalcemia or hypercalciuria during calcipotriol therapy, with most occurring in patients who exceeded the recommended dosage of 100 g/week. All episodes of hypercalcemia or hypercalciuria have resolved on discontinuation of treatment. Furthermore, there were no reports of any significant abnormalities in hematologic and biochemical laboratory parameters with twice daily calcipotriol ointment 50 μg/g in clinical trials. Limited data from short term studies of 8 weeks’ duration indicated that calcipotriol ointment 50 μg/g twice daily was well tolerated in 99 children aged 2 to 15 years. No serious adverse events were reported. Adverse events were similar to those observed in adults. In a short term study, adverse events possibly or probably related to calcipotriol therapy were lesional and perilesional irritations (11 to 16% of patients), irritations of the face and/or scalp (5 to 6%), various skin rashes (6%) and worsening of psoriasis (2%). In addition, there were no significant changes in hematologic or biochemical laboratory parameters, including no clinically relevant changes in liver and renal function tests or serum calcium levels. Although data are very limited, a study in 12 children (aged 8 to 15 years) indicated that calcipotriol ointment 50 μg/g twice daily (for up to 106 weeks; mean duration of therapy was 40 weeks) was well tolerated with no serious adverse effects reported.

Dosage and Administration

Calcipotriol ointment 50 μg/g is approved for the treatment of moderate plaque psoriasis. It should be applied once or twice daily to the affected area up to a maximum of 100 g/week in adult patients. In Japan, the maximum recommended adult dosage is 90 g/week. Currently, in the US there are no dosage recommendations available for the use of calcipotriol in children, whereas in the UK the maximum recommended dosage in children aged 6 to 12 years is 50 g/week increasing to 75 g/week in those over 12 years of age; no dosage recommendations are available for children less than 6 years of age. Calcipotriol should not be applied to the face or eyes, and hands should be washed to prevent this happening inadvertently. Calcipotriol is contraindicated in patients with known calcium metabolism disorders, evidence of vitamin D toxicity or hypersensitivity to calcipotriol or any other constituents of the ointment. The use of the drug during pregnancy is not recommended.     

Comparison of clinical effects of psoriasis treatment regimens among calcipotriol alone,narrowband ultraviolet B phototherapy alone,combination of calcipotriol and narrowband ultraviolet B phototherapy once a week,and combination of calcipotriol and narrowband ultraviolet B phototherapy more than twice a week

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.     

A comparison of twice-daily calcipotriol ointment with once-daily short-contact dithranol cream therapy: a randomized controlled trial of supervised treatment of psoriasis vulgaris in a day-care setting

BACKGROUND: Calcipotriol has become a first-line treatment for psoriasis. Its efficacy and safety have been shown in many comparative clinical trials carried out in outpatients. In a comparative study in patients visiting the outpatient department once every 14 days, it was shown that calcipotriol was more effective and better tolerated compared with dithranol. OBJECTIVES: To compare the clinical efficacy of calcipotriol ointment with that of dithranol cream in a supervised treatment regimen. METHODS: In a multicentre randomized controlled trial in six centres in the Netherlands, 106 patients with chronic plaque psoriasis were included, 54 receiving calcipotriol ointment twice daily and 52 dithranol cream once daily. Patients were treated at the day-care centre, using the care instruction principle of daily visits during the first week and twice-weekly visits subsequently for up to 12 weeks. RESULTS: This study failed to prove that calcipotriol is as efficacious as dithranol when used in a day-care setting (noninferiority test). The mean percentage reduction in Psoriasis Area and Severity Index from baseline to end of treatment was 57.0% in the calcipotriol group vs. 63.6% in the dithranol group. However, the two-sided test for superiority indicated no statistically significant difference between the treatment groups (P = 0.39). At the end of treatment, 15% of the patients treated with calcipotriol ointment and 25% of those treated with dithranol cream did not require any further treatment. Although calcipotriol ointment appeared to be more effective during the first 8 weeks, a difference was no longer apparent at 12 weeks. In comparison with the high number of drop-outs due to cutaneous side-effects in the calcipotriol group, the frequency of a tolerable degree of irritation appeared to be higher in patients treated with dithranol. However, concomitant corticosteroid treatment of dithranol irritation in seven patients may have contributed to this difference between both treatments. Moreover, patients receiving therapy with calcipotriol ointment experienced fewer application-related skin and subcutaneous tissue disorders than patients treated with dithranol cream: 21 of 53 (40%) and 37 of 52 (71%), respectively. This difference is statistically significant (P = 0.001). CONCLUSIONS: The hypothesis that calcipotriol ointment might be at least as effective as dithranol cream in the day-care setting could not be proven in the present study. Whereas calcipotriol has become a mainstay in the routine outpatient treatment of psoriasis not requiring a day-care setting, dithranol treatment, being difficult as a routine outpatient therapy, has increased efficacy and improved tolerability if the treatment is carried out in a day-care setting.