Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

BACKGROUND: Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. METHODS: A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. Thirty-six patients with nearly bilaterally symmetrical SPP lesions on the limbs were instructed to apply 5% coal tar ointment overnight on one side once daily and 0.005% calcipotriol ointment on the other side twice a day. All patients were advised to expose both sides to the sun for 2 h every day. Psoriatic lesions and progress during treatment were evaluated using the severity (0-3) scale of erythema, scaling and induration (ESI score). Evaluation was carried out every 2 weeks during the treatment period and monthly during follow-up. At the end of 12 weeks, patients with > 75% reduction in the ESI score were considered to be markedly improved, those with 51-75% reduction to be moderately improved, those with 26-50% reduction to be minimally improved and those with < 25% to be non-responders. Self-assessment by the patients regarding the efficacy and acceptability of the two modalities was on a five-point scale. Serum calcium, serum phosphate, total and differential serum proteins, 24-h urinary calcium and phosphate were monitored both at baseline and after completion of therapy. RESULTS: Thirty of the 36 recruited patients completed the study. The difference in clinical response between the two sides was statistically significant at 4, 6 and 8 weeks, with the percentage reduction in ESI score with calcipotriol being 65.7 +/- 12.2% compared with 45.8 +/- 16.6% with coal tar at 8 weeks (P < 0.01, t = 6.4). However, the difference in clinical response at 10 and 12 weeks between the two sides was not significant, with a mean reduction of 71.9 +/- 13.3% in ESI score on the calcipotriol-treated side compared with 69.4 +/- 15.4% with coal tar ointment (P > 0.05). In the follow-up period of 8 weeks, recurrence of lesions was noted in 10% of patients treated with calcipotriol compared with 16.7% in those treated with coal tar after an average period of 6 +/- 1.2 and 5 +/- 1.3 weeks, respectively (P > 0.05). CONCLUSIONS: It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.     

Calcipotriol cream: a review of its use in the management of psoriasis

Published data are reviewed on the pharmacology, efficacy, tolerability, and pleasantness of the vitamin D(3) analogue calcipotriol in a cream formulation (Daivonex/Dovonex cream; LEO Pharma AS, Denmark) in the treatment of psoriasis. Calcipotriol cream monotherapy is more effective than placebo, and as effective as betamethasone valerate cream and coal tar in psoriasis. A regimen of morning-cream and evening-ointment is equally effective as twice-daily calcipotriol ointment and is preferred by patients. Calcipotriol cream is also a highly efficacious maintenance treatment used alone or in an alternating regimen with calcipotriol/betamethasone dipropionate ointment. Short- and long-term trials have demonstrated that calcipotriol cream is well tolerated by patients with psoriasis. Irritation is observed less frequently than with calcipotriol ointment, making the cream very suitable for children and thin or sensitive areas, such as flexures or (off-label use) the face. Calcipotriol cream is generally preferred to the ointment formulation, as shown by preference testing, and leads to improved patient compliance. In conclusion, calcipotriol cream is not only an effective treatment for psoriasis but is pleasant to use and well tolerated even in sensitive areas. Therefore, calcipotriol cream is particularly useful for the maintenance treatment of psoriasis, after induction therapy with a fast-acting vitamin D/steroid two-compound product.     

A comparative study of calcipotriol ointment and tar in chronic plaque psoriasis

The antipsoriatic efficacy, tolerability and safety of calcipotriol ointment was compared with tar in a prospective, right/left randomized, investigator-blinded controlled study. Calcipotriol ointment 50 μg/g twice daily was applied to one-half of the body. On the opposite side, white soft paraffin was applied in the morning, and coal tar solution BP 15% v/w in aqueous cream in the evening. Thirty patients with stable chronic plaque-type psoriasis were recruited. Assessments were made at 2,4 and 6 weeks. Three patients were withdrawn from the study. A decrease in PASI score was seen on both sides at 2, 4 and 6 weeks. The differences from baseline between the two treatments were statistically significant in favour of calcipotriol. Improvement with calcipotriol was rapid in the first 2 weeks of treatment. With tar, significant improvement occurred only after 4 weeks of treatment. The differences in the scores for erythema, induration and desquamation from baseline between the two treatments were also statistically significantly in favour of calcipotriol at all evaluation points. Seven patients developed irritation on the calcipotriol-treated side, but there were no adverse effects on the tar-treated side. In two patients, itching associated with psoriasis was reduced by the calcipotriol. Although the mean serum calcium and phosphate levels remained within the normal ranges after 6 weeks' treatment, there were significant changes in their values compared with baseline.     

A comparative trial of Clinitar versus hydrocortisone cream in the treatment of atopic eczema

Thirty patients with mild to moderate bilateral atopic eczema were treated on one side of the body with a new purified coal tar cream (Clinitar) and on the other side with 1% hydrocortisone cream, for 4 weeks. The degree of infiltration of the skin erythema, lichenification, excoriations and dryness were assessed. Both treatments were equally effective in reducing symptoms and there was also no difference in patient preference and cosmetic acceptability.     

Comparison of calcipotriol and coal tar in conjunction with sun exposure in chronic plaque psoriasis: a pilot study

This study was a left-right comparison of the efficacy of 0.005% calcipotriol ointment and 5% coal tar ointment in conjunction with sun exposure in 10 patients with stable plaque psoriasis. After four weeks of therapy, the calcipotriol treated site showed a significantly faster fall in PASI compared to the coal tar treated site. At eight weeks, this difference was not significant with both sides showing comparable improvement in lesions, as shown by PASI values. There were no significant side effects from either therapy. We conclude that both calcipotriol and coal tar ointments have comparable efficacy in treating stable plaque psoriasis when used simultaneously with sun exposure, although the initial response to calcipotriol is faster.     

Clinical trial of the efficacy and safety of oral etretinate with calcipotriol cream compared with etretinate alone in moderate-severe psoriasis

BACKGROUND: The aim of this clinical trial was to assess the efficacy and safety of calcipotriol cream associated with oral etretinate compared with etretinate alone in the treatment of moderate-severe psoriasis. METHODS: This controlled multicenter trial, within patients (hemiparts), enrolled 86 in- or out-patients (62 males, 24 females), mean (+/-SD) age 57.1 +/- 14.2 years, with psoriasis vulgaris on both sides of the body, and mean (+/-SE) baseline PASI score (Psoriasis Area and Severity Index) 30.7 +/- 0.9. All patients took oral etretinate 50 mg/day and applied calcipotriol cream (50 microg/g) on one half of their body twice a day. Treatment was continued for 9 weeks, and patients were seen every 3 weeks. RESULTS: At the end of the first 3 weeks the PASI score indicated a significant clinical difference between the two sides of the body (P < 0.001, ANOVA), with a reduction of 50.7% in the score for the calcipotriol-treated half, compared with a 39% reduction for the untreated half. By the 9th week of treatment the PASI score was 81.4% lower on the treated half, and 70.3% on the untreated side (P < 0.001, ANOVA). CONCLUSIONS: These findings suggest that patients with moderate-severe psoriasis might benefit from treatment with etretinate plus calcipotriol, with the aim of achieving a faster response and an overall smaller total dose of etretinate.     

Efficacy and Tolerability of a Cosmetically Acceptable Coal Tar Solution in the Treatment of Moderate Plaque Psoriasis

Background: Topical coal tar is awell known and effective treatment for psoriasis, but the messiness, staining, odor, and inconvenience associated with its use make patient satisfaction and compliance a challenge. Objective: To determine the efficacy, patient tolerability, and cosmetic acceptability of a new topical liquor carbonis distillate (LCD) 15% solution compared with calcipotriene (calcipotriol) cream in patients with moderate, chronic plaque psoriasis. Study Design: A randomized, single-blind, active-controlled, parallel-group, clinical trial consisting of a 12-week treatment phase and a 6-week post-treatment follow-up phase. Setting: Outpatient dermatology research unit in an academic hospital. Patients: Sixty adults with moderate, chronic plaque psoriasis (3–15% body surface area affected) not receiving other psoriasis therapies. Intervention: Patients were randomized to apply either an LCD 15% solution (Psorent®) or a commercially available calcipotriene 0.005% cream (Dovonex®) to their psoriasis areas (excluding the head) twice daily at home for 12 weeks. Assessments: A blinded investigator evaluated the patients’ psoriasis using a modified Psoriasis Area and Severity Index (PASI) that excluded the head, and a Physician’s Global Assessment (PGA) scale at weeks 0 (baseline), 2, 4, 8, and 12 (end of treatment), and 18 (6 weeks after treatment was withdrawn). Patients assessed their psoriasis symptoms and quality of life and completed a cosmetic acceptability survey about their medication. Outcome Measures: The changes in the baseline PASI scores after 12 weeks of treatment were compared between LCD and calcipotriene groups. Additional comparisons were performed for success rates during treatment (PASI 75 and PASI 50), changes in PGA scores, patient-reported psoriasis symptom scores, patients’ quality-of-life scores, and recurrence rates during post-treatment follow-up. Results: Both treatment groups showed improvement in psoriasis severity and quality of life. However, the LCD group had greater mean reductions in PASI scores: 58% vs 37% in the calcipotriene group (p < 0.05) at week 12. Additionally, the LCD group had more patients (14/27) with absent or minimal psoriasis on the PGA scale than the calcipotriene group (6/28) by the end of treatment (p < 0.05). LCD-treated patients also maintained their improvement better than calcipotriene-treated patients through week 18 after treatment was withdrawn for 6 weeks. Both treatments were well tolerated and cosmetically acceptable to patients. Conclusion: The newly formulated LCD solution, applied twice daily at home for 12 weeks, was more effective and as well tolerated and cosmetically acceptable as the calcipotriene cream over 12 weeks of treatment and 6 weeks of follow-up. The LCD solution is a patient-accepted and effective corticosteroid-sparing treatment alternative for psoriasis patients. Clinical Trial Registration Identifier: NCT00705900     

Patient attitudes to topical antipsoriatic treatment with calcipotriol and dithranol

OBJECTIVE: Assessment of patient preference for antipsoriatic treatment with calcipotriol ointment or short-contact dithranol cream. METHODS: Two hundred and fifty-eight psoriatic patients treated with calcipotriol (n = 138) or dithranol (n = 120) for up to 3 months, assessed the acceptability of treatment, overall satisfaction with treatment, their treatment preference using the 'willingness to pay' principle and selected their treatment of choice. RESULTS: Overall satisfaction with calcipotriol was significantly better (72.7%, dithranol 60.3%; odds ratio 1.75, 95% CI 1.03, 2.99: P = 0.04). Patients considered calcipotriol a more acceptable treatment than dithranol in its appearance, smell, non-irritancy, method and ease of application and lack of staining. Dithranol was considered less sticky than calcipotriol. Patients were 'willing to pay' a mean of pound sterling 12.16 monthly for calcipotriol and pound sterling 10.66 monthly for dithranol. 'Willingness to pay' did not correlate well with overall treatment satisfaction and was not correlated with household income. Calcipotriol was the preferred treatment of choice (calcipotriol 63%, dithranol 24%). CONCLUSION: Patients with psoriasis prefer treatment with calcipotriol ointment over short-contact dithranol cream.     

皮肤镜观察外用药物治疗寻常性银屑病的效果及分析

目的皮肤镜动态观察寻常性银屑病外用卤米松乳膏、卡泊三醇软膏和卤米松乳膏/卡泊三醇软膏治疗后的疗效,及皮损血管的改变和临床评分mPASI的相关性。方法选择2018年6月-2018年9月在本院就诊的30例寻常性银屑病患者,随机分为2组,一组给予卤米松乳膏外用,另一组给予卡泊三醇软膏外用,30例患者的一侧上肢皮损给予卤米松乳膏/卡泊三醇软膏外用。患者于治疗0、2、4及6周使用皮肤镜观察皮损处血管的变化,同时对观察皮损做mPASI评分并记录,比较3种治疗方法的皮损mPASI评分与血管指标的差异及治疗后mPASI评分与血管直径随时间的关系。结果卤米松乳膏/卡泊三醇软膏的局部治疗皮损临床评分和皮肤镜血管变化(血管直径及血管密度)与单独外用卤米松乳膏、卡泊三醇软膏的恢复更明显。银屑病皮损临床评分mPASI与血管球直径随时间的变化趋势一致。结论卤米松乳膏/卡泊三醇软膏局部外用治疗寻常性银屑病的效果优于单独应用;皮肤镜在银屑病皮损恢复情况及临床药物疗效的观察中具有临床价值。     

Efficacy of betamethasone valerate mousse in comparison with standard therapies on scalp psoriasis: an open,multicentre, randomized,controlled, cross-over study on 241 patients

BACKGROUND: The scalp is a common area for plaque psoriasis. Corticosteroid-based lotions are the most widely used therapy in this clinical setting. A new formulation of betamethasone valerate 0.12% in a thermophobic, low-residue foam vehicle (Bettamousse trade mark, Mipharm, Italy; BVM) is available for the treatment of scalp dermatoses. OBJECTIVES: In an open, investigator-blinded, multicentre (28 dermatology clinics), randomized, cross-over study, the efficacy, safety and patient acceptability of BVM in scalp psoriasis were evaluated in comparison with standard therapies (ST, i.e. corticosteroids or vitamin D analogues). ST were chosen by each centre according to its usual therapeutic protocols. METHODS: In total, 241 patients with moderate to severe scalp psoriasis participated in the trial. After a 2-week run-in period, each active treatment (BVM or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a 'target' lesion for erythema, scaling, itching and burning using a five-point grading score. Patient treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay-Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. BVM was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens. RESULTS: Analyses were by intention-to-treat. Two hundred and ten patients concluded the study. Fifteen patients withdrew from the study during BVM treatment, and 16 during ST (not significantly different). Both treatments were well tolerated. At baseline, the mean +/- SD clinical global score (the 'Sum' score = erythema + scaling + itching + burning) was 7.6 +/- 2.6. The ST chosen were topical corticosteroids (55% of cases; mainly mometasone and betamethasone dipropionate) or calcipotriol lotion (45% of cases). At the end of active treatments, BVM was significantly superior to ST (P < 0.001) in reducing, as compared with baseline, the mean +/- SD Sum score (1.5 +/- 1.9 with BVM and 3.1 +/- 2.7 with ST). During BVM treatment, 88% (95% confidence interval, CI 82-94%) of patients had a complete or nearly complete resolution of scaling in comparison with 66% (95% CI 58-74%) during ST therapy (P < 0.001). BVM was also considered an easier and more convenient formulation to use in comparison with ST (P < 0.01). CONCLUSIONS: BVM is more effective than lotion-based ST commonly used in the treatment of scalp psoriasis, and has higher patient acceptability.     

A comparative study of calcipotriol and anthralin for chronic plaque psoriasis in a day care treatment center

Eighteen patients with symmetric plaque-type psoriasis were recruited for an open, controlled, bilateral half-body comparison study to evaluate the efficacy of calcipotriol/tar/UVB vs. anthralin/tar/UVB in a day care treatment setting. No patient had been on systemic antipsoriatic agents for at least 3 months prior to enrolment. One half-body was arbitrarily assigned to treatment with gradually increasing concentrations of anthralin as tolerated. The other half-body received calcipotriol ointment twice daily. Both sides received UVB and additional coal tar distillate in accordance with our standard day care regimen. Patients who were admitted to the day care program attended the clinic for UVB, anthralin, and calcipotriol on weekdays for two consecutive weeks. Anthralin was applied to psoriatic plaques on one side in the following fashion: anthralin 0.1% with salicylic acid 3% in zinc oxide paste on days 1 and 2; anthralin 0.2% with salicylic acid 3% in zinc oxide paste on days 3–5; anthralin 1% with salicylic acid 3% in hydrophilic petrolatum for 60 min on days 8–10 to thicker lesions; and anthralin 2% with salicylic acid 3% in hydrophilic petrolatum for 60 min on day 11 to thicker lesions. On the contralateral side, calcipotriol ointment 0.05 μg/mL (Leo Pharmaceuticals, Ajax, Ontario) was applied to lesions twice daily. No anthralin or calcipotriol was applied on weekends. All patients applied coal tar oil 50% (Doak Oil Forte, Trans CanaDerm, St-Laurent, Québec, equivalent to 5% coal tar distillate) with salicylic acid 5% in hydrophilic petrolatum to their lesions at home in the evenings and on weekends. UVB (FSX72T12 lamps, National Biologic Corporation, Twinsburg, Ohio) was administered twice daily on weekdays in increasing doses as tolerated (to erythema) prior to the application of the topical medications. No trial medications were applied to the face, scalp, or genital regions. For clinical evaluation, the standard Psoriasis Activity and Severity Index (PASI) score¹ was modified by splitting the score for area under 10%; the modified score (mPASI) for an area of coverage of 1%–4% was 0.5 and for an area of 5%–9% was 1. The head and neck area was excluded from the analysis since neither anthralin nor calcipotriol was used at these sites. Each half-body was considered to represent 100% in the area score determination. The maximum modified score for each side was 64.8 (vs. 72 in the standard PASI scoring system¹). Clinical evaluations were completed at days 0 (baseline), 3, 7, 10, and 42. The primary end-point was day 10. On day 10, patients were asked to compare the calcipotriol ointment to the anthralin on a five-point scale in terms of efficacy and irritancy and to state their future preferred treatment modality. Following discharge from day care, patients were continued on outpatient UVB and tar treatments three times weekly and asked to return for a repeat clinical assessment after 4 weeks (day 42). Blood samples taken prior to treatment and at day 10 were analyzed for serum calcium. Comparisons of treatment efficacy were based on changes in the mPASI scores from onset of treatment to day 10, as well as on the corresponding percentage changes. Analyses were carried out using the Wilcoxon test. Subjective patient comparisons of effectiveness and irritancy, as well as patient preference, were tested for equiprobability using the chi-square goodness-of-fit test with an examination of the adjusted residuals.     

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.     

A multicentre, parallel-group comparison of calcipotriol ointment and short-contact dithranol therapy in chronic plaque psoriasis

Short-contact treatment with dithranol (anthralin) is a widely used treatment for chronic plaque psoriasis. Although effective, it causes staining and irritation, and is therefore inconvenient. Calcipotriol is a recently developed vitamin D analogue which is effective and easy to use. To evaluate the relative efficacy, safety and acceptability of these treatments a multicentre, open, randomized, parallel-group comparison was performed. Four hundred and seventy-eight patients with chronic plaque psoriasis were randomized to use one of the two treatments for 8 weeks. One group applied calcipotriol ointment (50 micrograms/g) twice daily. The other used a single application for 30 min each day of Dithrocream in the highest concentration tolerated. Severity of psoriasis was assessed by modified PASI score at baseline, and after 2, 4, and 8 weeks of treatment. A five-point scale was used by subjects and by investigators as an additional assessment of overall response, and a similar scale was used by subjects to grade acceptability. Total serum calcium was monitored at baseline and after 2 and 8 weeks on treatment. The mean PASI score fell from 9.1 to 4.7 after 8 weeks on dithranol (P < 0.001), and from 9.4 to 3.4 on calcipotriol (P < 0.001). The difference between the two treatments was significant in favour of calcipotriol at 2 weeks (P < 0.001), and remained so at subsequent assessments. At 8 weeks the difference between mean improvements in scores for the two groups was 1.6 (95% confidence interval 0.5-2.7). Efficacy grading by subjects and investigators, and acceptability grading by subjects, were all significantly better for calcipotriol.(ABSTRACT TRUNCATED AT 250 WORDS)     

0.3% Tacrolimus gel and 0.5% Tacrolimus cream show efficacy in mild to moderate plaque psoriasis: Results of a randomized, open-label, observer-blinded study

The efficacy and safety of 0.3% tacrolimus gel and 0.5% tacrolimus cream compared with calcipotriol ointment were evaluated in adults (n = 124) with mild to moderate plaque psoriasis. Treatment was twice daily for a maximum of 12 weeks. Clinical efficacy was assessed by the percentage change in the local psoriasis severity index of a target lesion between baseline and week 12. By week 12, the median percentage changes in local psoriasis severity index of the target lesions in the tacrolimus gel, tacrolimus cream and calcipotriol groups were 55.6%, 50.0% and 58.6%, respectively (no statistically significant differences). Clinical improvement was observed after one week and increased throughout the study. Tacrolimus-treated patients experienced more application site skin burning (tacrolimus gel and cream both 31.0% versus 7.5% for calcipotriol; p = 0.011). Skin burning was mostly mild in intensity and decreased substantially after 1 week of treatment. There were no differences in the nature and incidence of infections and no clinically relevant changes in laboratory values.     

Comparative effects of two different calcipotriol (MC 903) cream formulations versus placebo in psoriasis vulgaris. A Randomised,Double-Blind,Placebo-Controlled,Parallel Group Multi-Centre Study1

Background Calcipotriol ointment is an effective treatment For psoriasis vulgaris. Although cream formulations have a less emollient effect they are often more acceptable to patients. Objective To compare calcipotriol 50 μg/g in two different cream formulations with vehicle in patients with psoriasis vulgaris. Method A randomised, double-blind, parallel group, multi-centre, comparison of cream A in which calcipotriol 50μg/g is dissolved, cream B in which calcipotriol 50 μg/g is suspended as tine particles and vehicle. A 2-week wash-out period was followed by 8 weeks double-blind treatment.     

Vitamin B(12) cream containing avocado oil in the therapy of plaque psoriasis

BACKGROUND: There are already many effective topical therapies available for use in the treatment of chronic plaque psoriasis. Unfortunately, these treatments are often associated with a rather significant risk of undesirable effects. OBJECTIVE AND METHODS: In this randomized, prospective clinical trial, the effects of the vitamin D(3) analog calcipotriol were evaluated against those of a recently developed vitamin B(12) cream containing avocado oil in an intraindividual right/left-side comparison. The trial population consisted of 13 patients, 10 men and 3 women, with chronic plaque psoriasis. The observation period was 12 weeks; the effects of therapy were assessed on the basis of a PASI score adapted to the right/left-side comparison technique, the subjective evaluations of the investigator and patients and the results of 20-MHz sonography. RESULTS: There was a more rapid development of beneficial effects with the use of calcipotriol in the initial 8 weeks, although differences in effects were significant only at the time point of therapy week 8 (p < 0.05). After 12 weeks, neither the PASI score nor 20-MHz sonography showed significant differences between the two treatments. While the efficacy of the calcipotriol preparation reached a maximum in the first 4 weeks and then began to subside, the effects of the vitamin B(12) cream containing avocado oil remained at a constant level over the whole observation period. This would indicate that the vitamin B(12) preparation containing avocado oil may be suitable for use in long-term therapy, a hypothesis further supported by the fact that the investigator and the patients assessed the tolerability of the vitamin B(12) cream containing avocado oil as significantly better in comparison with that of calcipotriol. CONCLUSION: The results of this clinical trial provide evidence that the recently developed vitamin B(12) cream containing avocado oil has considerable potential as a well-tolerated, long-term topical therapy of psoriasis.     

Comparative efficacy of calcipotriol (MC903) cream and betamethasone 17-valerate cream in the treatment of chronic plaque psoriasis. A randomized, double-blind, parallel group multicentre study

The efficacy, safety and tolerability of calcipotriol cream was compared with betamethasone 17-valerate cream in the treatment of plaque-type psoriasis in a multicentre double-blind, parallel group study. Patients with stable mild-to-moderate chronic disease were randomized to treatment with either calcipotriol, 50 μg/g, in a cream formulation (210 patients) or betamethasone 17-valerate cream, 1 mg/g (211 patients). After a wash-out period of 2 weeks. the treatment was applied twice daily, without occlusion. for 8 weeks or to complete clearing. The severity of psoriasis was assessed using the PASI at baseline and after 4 and 8 weeks treatment. The mean percentage reduction of PASI from baseline to end of treatment was 47.8% in the calcipotriol group and 45.4% in the betamethasone group. The reduction from baseline was highly significant in both groups. but the differecnce between the groups was not significant. There was a difference in the reduction in thickness of the lesions in favour of calcipotriol. The investigator's as well as the patient's overall assessment of treatment response at end of treatment showed no difference between the two treatment groups. Treatment-related adverse events were more frequent with calcipotriol thanbetamethasone. Lesional/perilesional irritation was reported in 16% and 9% (P=0.03). and facial irritation in 10% and 0.5% (P<0.001), respectively. No change was found in serum levels of calcium. Calcipotriol in a cream formulation was effective, safe well-tolerated. and equal in effect to betamethasone valerate cream.     

Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis

Owing to its anti-inflammatory, antipruritic, vasoconstrictive, and immune-modulating properties, clobetasol propionate is used to treat psoriasis. This study was conducted to evaluate the efficacy, safety, and cosmetic acceptability of clobetasol propionate lotion compared with its vehicle and with clobetasol propionate cream in the treatment of moderate to severe plaque-type psoriasis. A total of 222 patients were treated. After 4 weeks of treatment, clobetasol propionate lotion was more efficient than vehicle lotion and of equivalent efficacy as clobetasol propionate cream. Cosmetic acceptability was significantly better with clobetasol propionate lotion than with clobetasol propionate cream. Clobetasol propionate lotion was efficient, safe, and well tolerated and offers a significantly higher cosmetic advantage in the treatment of moderate to severe plaque-type psoriasis compared with clobetasol propionate cream.     

A randomized, investigator-masked clinical evaluation of the efficacy and safety of clobetasol propionate 0.05% shampoo and tar blend 1% shampoo in the treatment of moderate to severe scalp psoriasis

The clinical benefit of currently available tar blend shampoos for the treatment of scalp psoriasis is restricted due to their limited efficacy, low cosmetic appeal and potential for carcinogenicity. This 4-week multicentre, randomized, parallel-group, investigator-masked study included 162 subjects and aimed to compare the efficacy, safety and cosmetic acceptability of clobetasol propionate 0.05% shampoo versus a currently marketed tar blend 1% shampoo in subjects with moderate to severe scalp psoriasis. Clobetasol propionate shampoo was superior to tar blend shampoo with respect to all efficacy variables tested (p<0.001): Total and Global Severity Score; erythema; plaque thickening; desquamation; pruritus; total scalp area involved; and the subject's global assessment of clinical improvement. Both treatments were safe and well-tolerated. Furthermore, more subjects indicated that clobetasol propionate shampoo was more cosmetically acceptable than tar blend shampoo. Clobetasol propionate 0.05% shampoo is a good alternative to tar blend shampoo in the treatment of moderate to severe scalp psoriasis.