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.     

Long-term outcome of severe chronic plaque psoriasis following treatment with high-dose topical calcipotriol

We have previously reported the effectiveness of high-dose calcipotriol in extensive psoriasis. We now report the long-term outcome in patients following this treatment. Twenty-eight patients with severe psoriasis were treated as in-patients with high-dose topical calcipotriol for 2 weeks. There was a mean reduction in the psoriasis area and severity index of 65%. Sixty-nine per cent were controlled for 3 months and 42% for 6 months. The relapse rate was comparable with that following Ingram's regimen, the in-patient stay was shorter and the treatment more acceptable. Careful monitoring of calcium homeostasis is mandatory.     

卡泊三醇软膏和卤米松乳膏序贯疗法治疗斑块状银屑病临床观察

目的:观察卡泊三醇软膏和卤米松乳膏序贯疗法治疗斑块状银屑病的疗效及安全性.方法:76例银屑病患者随机分为卡泊三醇组(A组)36例和卡泊三醇软膏和卤米松乳膏序贯治疗组(B组)40例,A组患者每日涂药2次,B组患者按银屑病的序贯疗法用药.两组患者在疗后的第2周、4周、6周根据银屑病皮损而积和严重度指数(PASI)评分评判疗效,根据不良事件发生率分析其安全性.结果:随着疗程的增加两组患者的PASI评分均逐渐下降(P<0.01),B组下降更为明显(P<0.05);A组患者在治疗后2周、4周和6周的有效率分别为30.56%、55.56%和66.67%:B组患者的有效率分别为52.50%、67.50%和82.50%.B组的疗效明显优于A组(P<0.01);B组的不良事件发生率亦明显低于A组(P<0.01).结论:卡泊三醇软膏和卤米松乳膏序贯疗法治疗斑块状银屑病具有起效快、疗效好、不良反应小的优点.     

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.     

Proactive treatment with calcipotriol reduces recurrence of plaque psoriasis

Topical calcipotriol is a widely used treatment for plaque‐type psoriasis worldwide, and has been shown to improve psoriatic plaques as well as very potent corticosteroids. However, there remains the practical question of whether calcipotriol application should continue on healed pigmentation/depigmentation associated with psoriatic plaques. Therefore, we conducted a pilot clinical study to answer this question. Plaque‐type psoriatic patients not receiving systemic treatment were enrolled and treated with calcipotriol for 8 weeks (stage I) to achieve maximum effect. The patients were then divided into two groups: group A continued to apply calcipotriol to the entirety of the previous lesion (including pigmentation/depigmentation) regardless of whether skin was healed or not, while group B applied calcipotriol to the remaining lesion only. Patients were followed for 12 weeks (stage II) and dates of plaque recurrence were recorded. A total of 29 patients (13 men, 16 women) were enrolled. During stage I, reductions in scores for redness, induration and scale occurred in 40%, 47% and 55% of patients, respectively. After stage II was completed, group A (n = 19) showed a significantly better Kaplan–Meier curve of non‐recurrence than group B (n = 8, P < 0.01). The mean non‐recurrence duration was 76.8 ± 11.8 in group A and 35.0 ± 12.0 in group B. Our study showed that applying topical calcipotriol on seemingly healed psoriatic plaque lesions suppresses recurrence better than applying it only on remaining plaques. This finding may be important for instructing psoriatic patients on topical calcipotriol treatment.     

头皮银屑病外用药物的新选择——卡泊三醇倍他米松凝胶

头皮是银屑病最常见的好发部位之一.外用药物是治疗头皮银屑病的主要方法,维生素D3衍生物和糖皮质激素是目前最主要的外用药物.卡泊三醇倍他米松凝胶(赛美尔)(Xamiol)是一种含有卡泊三醇(50 μg/g)和二丙酸倍他米松(0.5 mg/g)的新型混合凝胶制剂.该文收集了国外赛美尔凝胶的临床试验及综述等文献资料,综述了赛美尔凝胶的作用机制、疗效和安全性,及其对患者依从性及生活质量的提高.赛美尔凝胶为头皮银屑病的外用药物治疗提供了新的选择.     

脉冲染料激光联合卡泊三醇倍他米松乳膏治疗甲银屑病一例并文献复习

甲银屑病的局部药物和物理治疗是目前治疗轻、中度甲银屑病研究的方向。本文报道595nm脉冲染料激光(Pulsed dye laser, PDL)联合卡泊三醇倍他米松乳膏治疗甲银屑病1例,并对PDL治疗甲银屑病的相关文献进行复习。     

Urine calcium excretion during treatment of psoriasis with topical calcipotriol

Urine calcium excretion is a very sensitive method of detecting vitamin D intoxication, and may rise in the absence of any apparent change in the serum level. Little attention has been paid to urine calcium levels during the large trials performed to assess the efficacy and safety of calcipotrioi in psoriasis vulgaris. There are some urine calcium data from short-term studies of average dose rates of calcipotriol. However, there are no published data on long-term usage, nor on the use of dose rates at the upper end of the licensed range (100 g/week). In a group of 20 patients, who were using typical quantities of calcipotriol ointment (50 μg/g) to treat psoriasis vulgaris, urine calcium excretion was measured prior to treatment, and then monthly for 1 2 months. There was no significant change in urine calcium over the year. In a separate group of 10 patients, who were using calcipotriol in the same concentration, at the maximum recommended rate of 100 g/week, urine calcium was measured at baseline, and after 2 and 4 weeks. There was a statistically significant rise in calcium excretion. This is the first trial to demonstrate that topical calcipotriol affects calcium homeostasis when used within the recommended dose range. Further studies are necessary to determine more precisely the magnitude and variability of this effect in a large group of individuals. For the present, caution is required when prescribing calcipotriol for any patient with known hypercalciuria or a history of renal stone formation. Consideration should be given to monitoring urine calcium excretion during prolonged use at dose rates approaching the recommended maximum.     

Comparative effects of calcipotriol (MC903) solution and placebo (vehicle of MC903) in the treatment of psoriasis of the scalp

The efficacy and safety of calcipotriol solution in the treatment of scalp psoriasis was compared with placebo (vehicle solution), in a multicentre double-blind, randomized, parallel-group study of 49 adult patients. Calcipotriol solution (50 μg/ml), or placebo, was applied twice daily over a 4-week period. At the end of the study period 60% of patients on calcipotriol showed clearance or marked improvement of their psoriasis compared with 17% on placebo. Overall assessment of treatment response showed that calcipotriol was superior to placebo in both investigator (P<0.001;95% confidence interval for difference 19.0–67.6) and patient (P<0.001; 95% confidence interval for difference 18.3–68.0) assessments. Total sign score for psoriasis (i.e. the sum of the scores for redness, thickness and scaliness) decreased by 48.9% in the calcipotriol group, and by 18.6% in the placebo group (P =0.005). Calcipotriol was significantly superior to placebo in reducing redness, thickness, scaliness and extent of psoriasis, and in the patients’assessment in reducing scalp flaking and itching. No statistically significant changes in blood biochemistry were detected during the study, and the solution was generally well tolerated.     

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 in the treatment of intertriginous psoriasis

Summary The purpose of this study was to examine the effectiveness and side-effects of the vitamin D analogue calcipotriol, applied topically to psoriatic skin lesions in intertriginous areas, in an open and uncontrolled trial. Twelve patients with psoriasis vulgaris who presented with psoriatic lesions in the axilla, and inguinal and anal folds, were treated with calcipotriol ointment (50μg/g) twice daily for 6 weeks. Examination and photographic documentation were performed before treatment, at 3 weeks of treatment, and at 6 weeks of treatment. The mean improvement in the extent and severity of the psoriatic plaques was determined with a semiquantitative grading system closely realted to the psoriasis area and severity index (M-PASI). Two of 12 patients showed insufficient response to therapy. Five of 12 patients showed a quick response within 3 weeks or less, and five of 12 patients showed a slow response which could be seen only after 6 weeks of treatment. Minimal burning was reported in one patient, slight lesional and/or perilesional irritation in five patients, and, in the remaining, no side-effects occurred. Topical calcipotriol is an effective and safe treatment for intertriginous psoriasis.