Primary studies included in this broad synthesis

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Fleming 2010

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Primary study

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Treatment of plaque psoriasis with the two-compound product calcipotriol/betamethasone dipropionate versus both monotherapies: An immunohistochemical study

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Journal The Journal of dermatological treatment
Year 2010
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This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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The combination of calcipotriol (Ccp) and topical corticosteroids increases efficacy and reduces side effects as compared to monotherapies. Previous studies suggest that such combinations may have an added value with respect to reduction of Tt-cell subsets. Aa two-compound product consisting of Ccp and betamethasone dipropionate (BD) has become available for the treatment of psoriasis and is clinically superior to both monotherapies. No immunohistochemical data are available on the in vivo effects of the two-compound formulation versus monotherapy with respect to the three key processes in psoriasis pathogenesis: epidermal proliferation, epidermal differentiation and inflammation. Ttherefore, 18 patients were treated with the two-compound product, Cp monotherapy or BD monotherapy for 6 weeks and biopsies were taken before and after 4 and 6 weeks of treatment. Tthese biopsies were stained immunohistochemically and analysed (semi)quantitatively. Aall treatments decreased the number of Ki-67+ cells and increased the keratin 15+ staining. Aa more pronounced reduction of epidermal and dermal Tt-cell markers and human beta defensin-2 was seen following combination treatment, compared with both monotherapies. In conclusion, the investigated markers of the skin immune system and epidermal proliferation indicated an added value of the two-compound product over both monotherapies.

Primary study

Unclassified

A randomized, multicenter study of calcipotriene ointment and clobetasol propionate foam in the sequential treatment of localized plaque-type psoriasis: short- and long-term outcomes.

Authors Koo J , Blum RR , Lebwohl M
Journal Journal of the American Academy of Dermatology
Year 2006
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This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: The merit of topical sequential therapy involving clobetasol foam and calcipotriene ointment has not been experimentally demonstrated. OBJECTIVE: We sought to assess the short-term efficacy of twice-daily clobetasol foam plus calcipotriene ointment compared with either agent alone as monotherapy and to compare long-term use of weekday calcipotriene ointment with or without clobetasol foam weekend pulse therapy. METHODS: Eighty-six subjects with plaque-type psoriasis received twice-daily treatment with clobetasol foam plus calcipotriene ointment or either agent as monotherapy for 2 weeks. Subjects in the combination group who achieved remission received weekday calcipotriene plus weekend pulse therapy with either clobetasol foam or vehicle for 6 months. RESULTS: After 2 weeks, psoriasis scores were significantly lower (P < .001) in the combination therapy group (adjusted trunk lesion score = 0.67) compared with monotherapy with either agent (lesion scores = 1.40 calcipotriene, 1.13 clobetasol foam). During the follow-up "weekday-weekend" phase, after 6 months, weekend pulse clobetasol foam was associated with a trend toward greater maintenance of remission compared with vehicle (92% improvement of trunk lesion vs 62%). LIMITATIONS: Small sample size may have hampered the detection of statistical significance during long-term therapy. CONCLUSION: The combination of clobetasol foam and calcipotriene ointment is significantly more effective than monotherapy for short-term treatment. Weekday calcipotriene plus weekend pulse clobetasol foam shows a consistent trend toward greater maintenance of remission.

Primary study

Unclassified

Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis

Journal Journal of the American Academy of Dermatology
Year 2003
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This article is included in 8 Systematic reviews Systematic reviews (8 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Calcipotriene and betamethasone dipropionate are topical treatments for psoriasis vulgaris. Their mode of action is different. Improved risk/benefit may result with concomitant use of the two compounds together. A new vehicle has been created with the objective of obtaining optimal stability of both calcipotriene and betamethasone dipropionate in the combination product. Objective: We compared the clinical efficacy of a fixed combination of calcipotriene and betamethasone dipropionate in a new vehicle to calcipotriene in the new vehicle, betamethasone in the new vehicle, and the new vehicle alone. Methods: This was an international, multicenter, prospective, randomized, double-blind, parallel-group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Results: The mean percentage reduction in PASI from baseline to end of treatment was 73.2% in the combination group (n = 301), 48.8% in the calcipotriene group (n = 308), 63.1% in the betamethasone dipropionate group (n = 312) and 28.8% in the new vehicle group (n = 107), (P < .001). The mean percentage reduction in PASI during the first week was 48.1%, 28.4%, 41.4%, and 21.5%, respectively (P < .001). Conclusion: A combination product of calcipotriene 50 μg/g and betamethasone dipropionate 0.5 mg/g in the new vehicle shows superior efficacy with a more rapid onset of action than the new vehicle containing either constituent alone in the treatment of psoriasis vulgaris.

Primary study

Unclassified

Calcitriol shows greater persistence of treatment effect than betamethasone dipropionate in topical psoriasis therapy

Journal The Journal of dermatological treatment
Year 2003
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This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: To establish the efficacy and duration of remission post-treatment of calcitriol 3 μg/g ointment in comparison with betamethasone dipropionate 0.05% ointment. METHODs: A randomized, multicentre trial was conducted in 258 adult patients with chronic plaque psoriasis. Calcitriol 3 μg/g ointment or betamethasone dipropionate 0.05% ointment was applied twice daily for 6 weeks or until complete clearance of lesions. Patients whose psoriasis cleared or were significantly improved and did not require treatment continuation at treatment endpoint were contacted over the following 8 weeks to determine whether relapse had occurred. RESULTS: Both treatments were efficacious; improvement in psoriasis or clearance of lesions (residual erythema was allowed) was recorded for 79% and 82% of patients receiving calcitriol or betamethasone dipropionate, respectively. Global improvement and global severity scores at treatment endpoint showed statistically significant differences in favour of betamethasone dipropionate (p<0.05); however, the absolute reduction in mean PASI (psoriasis area and severity index) was comparable between the groups. A statistically significantly (p<0.01) higher proportion of responders remained in remission (no worsening of the disease warranting new treatment) following calcitriol therapy (48%) than betamethasone therapy (25%). This is of potential importance to patients, physicians and healthcare suppliers. CONCLUSION: Twice-daily applications of either calcitriol 3 μg/g ointment or betamethasone dipropionate 0.05% ointment can be used to good effect in the treatment of chronic plaque psoriasis. However, the beneficial effect is likely to persist for longer following calcitriol treatment.

Primary study

Unclassified

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

Journal Acta dermato-venereologica
Year 2002
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This article is included in 7 Systematic reviews Systematic reviews (7 references) 1 Broad synthesis Broad syntheses (1 reference)

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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.

Primary study

Unclassified

Combination of calcipotriene (Dovonex) ointment and tazarotene (Tazorac) gel versus clobetasol ointment in the treatment of plaque psoriasis: a pilot study.

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Authors Bowman PH , Maloney JE , Koo JY
Journal Journal of the American Academy of Dermatology
Year 2002
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This article is included in 1 Systematic review Systematic reviews (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: Both calcipotriene and tazarotene have been shown to be effective in the treatment of psoriasis. No study has evaluated the effect of using both agents simultaneously. OBJECTIVE: Our purpose was to evaluate the effectiveness of combination treatment of psoriasis with calcipotriene ointment and tazarotene gel by comparing them with clobetasol ointment, a class I topical corticosteroid. A secondary objective was to evaluate the clinical compatibility of applying both agents at the same time. METHODS: This pilot study was a prospective, single-center, open-label, right/left comparison of 28 lesion pairs in 15 patients. It consisted of a 2-week treatment phase, followed by a 4-week post-treatment observation phase. RESULTS: All 15 patients completed the treatment phase of the study. At the end of the active treatment phase (end of week 2), calcipotriene- and tazarotene-treated lesions showed nearly identical reductions in scaling (P =.93), plaque elevation (P =.76), and overall lesional severity scores (P =.29) compared with their matched clobetasol-treated counterparts. Erythema improved significantly more in clobetasol-treated lesions (P <.05) during the treatment period, but differences became statistically insignificant during the post-treatment period (;P =.20). No patients had significant irritation from the treatments. During the post-treatment phase (weeks 3-6), all lesions worsened; plaque elevation returned somewhat more rapidly in calcipotriene- and tazarotene-treated lesions (P <.01), whereas changes in scaling, erythema, and overall lesional severity were not significantly different between the two treatment groups (P >.05). CONCLUSION: The nonsteroid combination of twice-daily calcipotriene ointment and once-daily tazarotene gel was not statistically different from twice-daily application of the class I corticosteroid clobetasol ointment in reducing psoriatic scaling, plaque elevation, and overall lesional severity over a 2-week period. There does not seem to be any chemical incompatibility between calcipotriene ointment and tazarotene gel that is clinically significant.

Primary study

Unclassified

A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris.

Journal Dermatology (Basel, Switzerland)
Year 2002
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This article is included in 9 Systematic reviews Systematic reviews (9 references) 1 Broad synthesis Broad syntheses (1 reference)

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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.

Primary study

Unclassified

Efficacy and tolerance of topical calcitriol 3 microg g(-1) in psoriasis treatment: a review of our experience in Poland.

Journal The British journal of dermatology
Year 2001
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This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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Although topical vitamin D3 derivatives have been used in the treatment of patients with psoriasis for the past 15 years, questions remain about the indications and limitations of application. Extensive personal experience gained during the development of calcitriol (1alpha25-dihydroxyvitamin D3) is therefore reviewed. Three double-blind, vehicle-controlled trials have revealed that calcitriol 3 microg g(-1) ointment (Silkis ointment, Galderma Laboratories) has very good clinical efficacy. In a left-right comparison with vehicle ointment, complete clearance of psoriatic lesions was achieved in 48% of sites treated with calcitriol and a further 41% showed considerable or definite improvement. The clinical response to calcitriol in another study was as good as, or even better than, that achieved with betamethasone valerate 0.1% ointment. A preparation containing calcitriol 15 microg g(-1) did not show any clinical superiority to the lower dose but was associated with a higher risk of hypercalciuria, particularly when applied to extensive skin lesions. These results suggest that calcitriol 3 microg g(-1) ointment is an effective and safe treatment for chronic plaque psoriasis.

Primary study

Unclassified

Topical triple-therapy of chronic stationary psoriasis (CSP). Increased healing effectiveness compared with a dithranol monotherapy

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Journal Aktuelle Dermatologie
Year 2001
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In a randomized, open and prospective study 30 patients (14 females and 16 males: average age 48.3 ± 17.3) with chronic-stationary psoriasis vulgaris were treated with three different combinations of topical drugs according to the following protocol. Three different groups were made up: Group 1 (n = 10, initial PASI 18,9) received a combination of mometason (mornings) - dithranol (at noon) - tazaroten 0.025% (evenings) (MDT), group 2 (n = 10, PASI 18.1) urea (mornings) -dithranol (at noon) - tazaroten 0.025% (evenings) (UDT) and group 3 (n = 10, initial PASI 18.8) calcipotriol (mornings) - dithranol (at noon) - tazaroten 0.025% (evenings) (CDT). During the therapy period of 4 weeks we documented the PASI-Score, infiltration, erythema, desquamation and perilesional irritation. 25 patients of 30 fulfilled the protocol, 5 patients had to drop out because of irritations (3xUDT; 1xMDT; 1xCDT). The collectives CDT (PASI: 18.8-1.9) and MDT (PASI: 18.9-2.0) revealed a significantly faster reduction of the PASI as the UDT collective (PASI: 18.1-3.1). Lokal irritations in the CDT and MDT groups occurred less often than in the collective UDT. There were no dithranol-hyperpigmentations in any collective. In comparison to former studies (1995; n = 30; classic dithranol-monotherapy) the time of therapy was reduced from 28.5 to 19.5 days in the collectives (MDT; CDT). That leads to an enormous potential for saving costs.