火疗联合卡泊三醇软膏治疗寻常型银屑病的疗效观察

目的观察火疗联合卡泊三醇软膏治疗寻常型银屑病的临床疗效。方法纳入符合寻常型银屑病诊断的患者,依据随机数字表法分为试验组及对照组,最终纳入统计66例,试验组33例,采用中医火疗联合卡泊三醇软膏方法治疗寻常型银屑病,对照组33例,采用卡泊三醇软膏外用的方法治疗寻常型银屑病。结果 2组患者在治疗前银屑病皮损面积与严重程度指数(PASI)评分无统计学意义,治疗2周后,2组患者PASI评分有统计学意义(P0.05),试验组与对照组经秩和检验2组间有效率差异有统计学意义(P0.05)。结论中医火疗联合卡泊三醇软膏治疗寻常型银屑病治疗安全、有效,值得研究与推广。     

卡泊三醇软膏联合口服中药治疗寻常性斑块状银屑病的临床疗效观察

目的 评价单纯外用卡泊三醇软膏和外用卡泊三醇软膏联合口服中药治疗对寻常性斑块状银屑病的疗效.方法 60例患者随即分成单纯外用卡泊三醇软膏组和外用卡泊三醇软膏联合口服中药组.疗程为12周.两组患者分别于治疗后进行临床疗效评估.结果 两组于第8周以后皮损PASI评分差异有统计学意义(P<0.05).治疗结束时,单纯西药组的有效率为73.3%,中西药联合组的有效率为93.3%,两组比较差异有统计学意义(P<0.05).结论 外用卡泊三醇软膏联合口服中药治疗寻常性斑块状银屑病优于单纯外用卡泊三醇软膏治疗.     

得肤宝联合敏泊斯皮肤修护精华乳治疗轻中度寻常型银屑病疗效观察

目的 观察卡泊三醇倍他米松软膏（得肤宝）联合皮肤修护精华乳治疗轻中度寻常型银屑病的临床疗效。方法 选取2021年9月—12月在皮肤科收治的117例轻中度寻常型银屑病患者,按照随机数字表法分为对照组57组,试验组60例,对照组皮损处外涂卡泊三醇倍他米松软膏1次/d;试验组在外用卡泊三醇倍他米松软膏1 h后,外涂敏泊斯皮肤修护精华乳,1次/d;疗程4周,每2周随访1次进行疗效比较。结果 2组患者治疗2周、4周后皮损面积、红斑、浸润、鳞屑评分及银屑病皮损面积和严重程度指数（PASI）评分、瘙痒程度评分均较治疗前下降,且试验组各项评分均低于对照组,差异有统计学意义（P<0.05）。结论 卡泊三醇倍他米松软膏联合皮肤修护精华乳治疗轻中度寻常型银屑病疗效显著,优于单用卡泊三醇倍他米松软膏。     

卡泊三醇倍他米松软膏联合卡泊三醇软膏序贯治疗寻常性银屑病的疗效观察

目的:评价卡泊三醇倍他米松软膏联合卡泊三醇软膏序贯治疗寻常性银屑病的有效性及安全性。方法 :采用多中心、随机、平行对照的研究设计,共纳入符合入选标准的221例轻度寻常性(斑块状)银屑病患者,随机分为A、B、C 3组,进行2个阶段的治疗。起始治疗阶段4周,3组均外用卡泊三醇倍他米松软膏,每日1次;维持治疗阶段8周,A组(序贯治疗组)予外用卡泊三醇软膏,B组(单药治疗组)予卡泊三醇倍他米松软膏,C组(对照组)予尿素软膏。3组总疗程均为12周,分别于治疗后4周、8周及12周进行疗效及不良反应的判定。结果:共184例患者完成所有疗程。起始阶段,使用卡泊三醇倍他米松软膏治疗4周后,3组银屑病皮损面积和严重程度指数(PASI)评分、患者生活质量(QOL)评分及瘙痒程度评分均明显改善(P均0.05)。维持阶段,继续治疗8周后,A组和B组PASI评分及QOL评分均得到进一步改善,但PASI评分下降程度差异无统计学意义(P0.05);A组达到PASI75及PASI50改善率与B组相似(P0.05),但达PASI90的改善率低于B组(P0.05);C组PASI评分及QOL评分较治疗4周时加重,维持治疗效果明显低于A组和B组(P0.05)。3组治疗对瘙痒评分均有进一步改善,各组比较差异无统计学意义(P0.05)。起始阶段及维持治疗阶段均未发生与研究药物相关的不良反应和不良事件。结论:卡泊三醇倍他米松软膏联合卡泊三醇软膏序贯治疗轻度寻常性银屑病疗效确切,且在维持阶段治疗中可进一步缓解症状,防止病情反复,与持续使用卡泊三醇倍他米松软膏疗效相似,安全可靠,更适用于长期治疗。     

糠酸莫米松乳膏联合卡泊三醇软膏软封包治疗斑块型银屑病疗效观察

目的探讨寻常性银屑病简单有效而且易操作的外用药物治疗方法。方法 283例寻常性银屑病患者随机分4组,分别进行糠酸莫米松乳膏外用、卡泊三醇软膏外用,以上两者联合外用,及两者联合外用后外涂凡士林软封包,4周后进行疗效观察。结果 4周治疗结束后,糠酸莫米松乳膏治疗银屑病的有效率为70.6%,卡泊三醇软膏的有效率为69.9%,糠酸莫米松乳膏联合卡泊三醇软膏的有效率为79.2%,糠酸莫米松乳膏联合卡泊三醇软膏加凡士林软封包的有效率为87.1%。糠酸莫米松乳膏联合卡泊三醇软膏加凡士林软封包的治疗效果明显好于不封包或单用者(P0.05)。结论糠酸莫米松乳膏、卡泊三醇软膏联合用药的疗效明显好于其单独用药;而两者联合用药后,外加凡士林软封包患者的疗效,明显好于不软封包的患者。     

卡泊三醇联合308nm准分子激光治疗寻常型银屑病疗效观察

目的观察308nm准分子激光联合卡泊三醇软膏治疗寻常型银屑病的临床疗效。方法摘取2016年10月～2018年10月我院门诊诊治的66例寻常型银屑病患者资料,33例接受卡泊三醇软膏治疗(对照组),33例接受308nm准分子激光联合卡泊三醇软膏治疗(研究组),比对两组治疗前后PASI评分、生存质量、不良反应。结果治疗2周、4周后研究组PASI评分(12.25±3.07)分、(2.11±1.79)分低于对照组(P 0.05),生活、心理等功能评分(87.04±4.23)分、(89.72±5.23)分,高于对照组(P 0.05),且不良反应率15.15%低于对照组36.36%(P 0.05)。结论寻常型银屑病患者行308nm准分子激光联合卡泊三醇软膏治疗可改善疾病症状,提高生存质量,降低不良反应率。     

钙泊三醇倍他米松乳膏与卡泊三醇软膏序贯治疗银屑病

目的:观察钙泊三醇倍他米松乳膏与卡泊三醇软膏序贯治疗银屑病患者的疗效及安全性。方法:将90例斑块状寻常性银屑病患者随机分为3组,第一组:外用钙泊三醇倍他米松乳膏4周(每日1次)+钙泊三醇倍他米松乳膏与卡泊三醇软膏交替使用2周(均每日1次,2种交替)+卡泊三醇软膏6周(每日1次);第二组:外用钙泊三醇倍他米松软膏6周+卡泊三醇软膏6周(均每日1次);第三组:外用卡泊三醇软膏12周(每日2次)。结果:3组患者治疗4、6、12周后银屑病皮损面积和严重程度指数(PASI)评分分别与各组治疗前比较,差异均有统计学意义(P均0.05)。第一组与第二组疗效均优于第三组,差异均有统计学意义(P均0.05),但第一组与第二组疗效比较,差异无统计学意义(P0.05)。结论:序贯疗法起效快且疗效优,为患者节省医疗开支并减少糖皮质激素的不良反应。     

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。     

中药联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯治疗寻常型银屑病(血热证)的疗效观察

目的观察中药内服及药浴联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯外用治疗寻常型银屑病(血热证)的临床疗效及安全性。方法通过随机方法将156例寻常型银屑病(血热证)患者分为试验组和对照组:2组均予中药汤药(半枝莲方)口服,1剂/d,中药药浴(生地榆方)隔日1次,试验组同时予钙泊三醇倍他米松软膏及钙泊三醇软膏序贯外用;共治疗10周,分别于4周、6周、10周时观察疗效,计算2组治疗前后皮疹PASI评分情况及总有效率,并监测生化指标(血常规、尿常规、肝肾功能)变化情况。结果治疗结束后试验组PASI评分为2.80±1.43,总有效率为96.1%,均高于对照组的4.23±2.76、87.5%,比较差异有统计学意义(P0.05);在治疗的不同阶段试验组的PASI评分均低于对照组,差异有统计学意义(P0.05);2组治疗前后血清生化的各项指标均大致正常。结论中药内服及药浴联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯治疗寻常型银屑病(血热证)有较好的临床疗效,安全性高。     

中药方剂浸浴联合外用钙泊三醇倍他米松软膏治疗寻常性银屑病57例临床观察

目的探讨中药方剂浸浴疗法联合外用钙泊三醇倍他米松软膏对寻常性银屑病患者的疗效。方法将114例寻常性银屑病患者随机等分为实验组(57例)和对照组(57例),实验组采用中药方剂浸浴联合外用钙泊三醇倍他米松软膏;对照组采用婴幼儿沐浴露浸浴联合外用钙泊三醇倍他米松软膏,两组疗程均为4周。结果治疗结束后,实验组有效率为82.46%,对照组为63.16%,差异具有统计学意义(P=0.04)。实验组治疗第2,4周的PASI分别为7.46±1.03和1.26±0.94与对照组的8.03±0.98和3.07±1.11比较差异具有统计学意义(P均0.01)。结论中药方剂浸浴联合外用钙泊三醇倍他米松软膏对寻常性银屑病患者的皮损症状起到很好地缓解作用,疗效显著。     

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.     

A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris

In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.     

钙泊三醇倍他米松软膏外用治疗寻常性银屑病的随机、双盲、对照研究

目的 探讨钙泊三醇倍他米松软膏外用治疗稳定期寻常性银屑病患者的临床疗效和安全性。方法 随机、双盲、阳性药物平行对照、多中心临床试验,入组320例寻常性银屑病患者,随机纳入试验组或对照组,疗程4周。试验组早晨外用模拟剂软膏基质,晚间外用钙泊三醇倍他米松软膏;对照组早晚单用卡泊三醇软膏。于首次用药后第1、2、4周观察临床疗效及安全性。结果 治疗4周后试验组PASI评分较基线下降百分比（79.23%）大于对照组（70.43%）,两组比较,P < 0.01;且在治疗1周后的疗效优于对照组。治疗4周后,PASI评分较基线下降≥75%的患者频数百分比比较,试验组有效率为73.03%,对照组为48.32%,P < 0.01,两组差异有统计学意义。治疗1、2、4周后试验组靶皮损红斑、浸润、鳞屑单独积分以及皮损总面积百分比等指标改善方面均优于对照组。320例受试者中不良事件发生率为18.1%,不良反应发生率为13.1%,两组间差异无统计学意义。药物不良反应主要为与皮肤有关的轻中度反应如瘙痒、毛囊炎、红斑等。结论 钙泊三醇倍他米松软膏治疗稳定期寻常性银屑病患者具有起效快、疗效好和用药方便、相对安全的特点。     

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.     

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.     

Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris

BACKGROUND: A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis. OBJECTIVES: This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma). METHODS: In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment. RESULTS: The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3. CONCLUSIONS: Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.     

Topical calcipotriol plus oral fumaric acid is more effective and faster acting than oral fumaric acid monotherapy in the treatment of severe chronic plaque psoriasis vulgaris

BACKGROUND: Calcipotriol is an established topical therapy for psoriasis vulgaris. OBJECTIVE: This study aimed to investigate whether the addition of calcipotriol to fumaric acid ester (FAE) monotherapy had an additive efficacy and an FAE-sparing effect in patients with severe plaque psoriasis. METHODS: This multicentre, randomised, double-blind, vehicle-controlled study included 143 patients for up to 13 weeks treatment. Group A received FAE tablets (Fumaderm) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle. Group B received FAE tablets + calcipotriol ointment (50 microg/g). Ointments were applied twice daily. Clinical response was assessed using percentage changes in the Psoriasis Area and Severity Index (PASI), from baseline to treatment end. RESULTS: The mean percentage change in the PASI was -76.1% in group B and -51.9% in group A, the difference between treatments was -24.2% (95% CI from -34.2 to -14.2%; p < 0.001). Group B responded more rapidly to treatment. Investigators' and patients' overall efficacy assessments were significantly more favourable for group B (p < or = 0.001). Group B was prescribed less FAE than group A. This difference was greatest at the last visit (mean daily dose 529 and 685 mg, respectively; p = 0.006). Overall adverse events in the two groups were similar. CONCLUSION: This study shows that the combination of calcipotriol and FAEs is significantly more effective and faster acting than FAE monotherapy in the treatment of severe plaque psoriasis. The combination has a slight FEA-sparing effect and therefore a superior benefit/risk ratio.     

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.     

Calcitriol ointment and clobetasol propionate cream: a new regimen for the treatment of plaque psoriasis

For psoriasis therapy, topical derivatives of vitamin D3 represent a versatile option: they can be used either alone or in combination with other agents such as topical corticosteroids. In this two-phase parallel-group study, the naturally occurring vitamin D3 analogue, calcitriol, was compared with the vitamin D analogue calcipotriol in 125 patients with chronic plaque-type psoriasis. The proposed treatment regimen was an initial bitherapy for 2 or 4 weeks, with clobetasol propionate 0.05% cream, a super potent topical corticosteroid applied in the morning and either calcitriol 3 mug/g ointment or calcipotriol 50 mug/g ointment applied in the evening, followed by monotherapy with either calcitriol or calcipotriol applied twice daily until endpoint week 12. Efficacy evaluations (global assessment of improvement, PASI and body surface area (BSA) affected) showed no significant differences between the two regimen groups at the primary endpoints (week 2 and week 12) or at any interim points. At week 2 the investigator's global assessment showed clinical success (psoriasis markedly improved, almost clear or clear) for more than 50% of the patients in both groups and for 48 (79%) and 56 (88%) patients, respectively in the calcitriol and calcipotriol regimen group at week 12. Least-square means analysis of PASI indicated the calcitriol regimen to be equivalent to the calcipotriol regimen. There were no significant differences between the two groups with regards to cutaneous safety or to incidence of adverse events. The present study shows that for the treatment of mild to moderate plaque psoriasis calcitriol 3 mug/g ointment can provide a safe and effective alternative to calcipotriol 50 mug/g ointment while being administered within a regimen based on a bitherapy with corticosteroids followed by a vitamin D3 maintenance monotherapy.     

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.