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P C M Van De Kerkhof - One of the best experts on this subject based on the ideXlab platform.

  • A new scalp formulation of Calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial
    British Journal of Dermatology, 2009
    Co-Authors: P C M Van De Kerkhof, Siegfried Segaert, V. Hoffmann, Alexander Vincent Anstey, L. Barnes, C. Bolduc, Kristian Reich, S. Saari, L. Vaillant
    Abstract:

    BACKGROUND: There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance. OBJECTIVES: To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol; LEO Pharma A/S, Ballerup, Denmark) containing Calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate), with the active ingredients as single compounds in the same vehicle. METHODS: This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (n = 568), betamethasone dipropionate 0.5 mg g(-1) (n = 563), or Calcipotriol 50 microg g(-1) (n = 286). The primary efficacy measure was the proportion of patients with 'absence of disease' or 'very mild disease' according to investigators' assessments at week 8. RESULTS: The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than the betamethasone dipropionate (61.0%, P = 0.0079) or Calcipotriol (43.4%, P < 0.0001) groups. The proportion of patients rating their scalp psoriasis as 'clear' or 'almost clear' was significantly higher for the two-compound scalp formulation (69.6%) than for betamethasone dipropionate (59.9%, P = 0.0006) or Calcipotriol (44.7%, P < 0.0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the Calcipotriol group. CONCLUSIONS: The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

  • topical treatment of mild to moderate plaque psoriasis with 0 3 tacrolimus gel and 0 5 tacrolimus cream the effect on sum score epidermal proliferation keratinization t cell subsets and hla dr expression
    British Journal of Dermatology, 2008
    Co-Authors: W.h.p.m. Vissers, E.m.g.j. De Jong, P E J Van Erp, I Van Vlijmen, P C M Van De Kerkhof
    Abstract:

    BACKGROUND: Tacrolimus gel 0.3% and tacrolimus cream 0.5% were studied and compared with Calcipotriol ointment 0.005%, as topical treatment for mild to moderate plaque psoriasis. Tacrolimus is able to inhibit several cellular processes thought to be important in the pathogenesis of psoriasis, e.g. the transcription of proinflammatory cytokines, keratinocyte hyperproliferation and the expression of HLA-DR in lesional psoriatic skin. METHOD: In the present study we investigated the effects of preparations of tacrolimus and Calcipotriol ointment on SUM score, hyperproliferation (Ki67-positive keratinocytes), keratinization (percentage keratin 10 (K10)-positive epidermal surface), T-cell subsets (CD4, CD8, CD45RO, CD45RA, CD2, CD25), cells expressing natural killer receptors and HLA-DR expression. The following three topical treatments were studied in chronic plaque psoriasis over a 12-week treatment period: Calcipotriol ointment 0.005% twice daily, tacrolimus gel 0.3% twice daily and tacrolimus cream 0.5% twice daily. RESULTS: The mean reductions in SUM score between day 0 and week 12 for Calcipotriol ointment, tacrolimus gel and cream were significant. Calcipotriol ointment, and tacrolimus gel and cream had a comparable effect on epidermal proliferation (Ki67-positive cells), but Calcipotriol is significantly more effective in normalizing differentiation (K10-positive epidermal surface). Calcipotriol and tacrolimus gel both reduced several lesional T-cell subsets significantly, whereas the effect induced by tacrolimus cream was modest. CONCLUSIONS: Calcipotriol and tacrolimus gel are comparable in reducing the SUM score, the number of Ki67-positive cells and T-cell subsets and HLA-DR expression, although Calcipotriol induces a more substantial improvement of keratinization.

  • 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
    British Journal of Dermatology, 2006
    Co-Authors: P C M Van De Kerkhof, O.q.j. Swinkels, P.g.m. Van Der Valk, M. Kucharekova, M A De Rie, H J C De Vries, R J Damstra, A P Oranje, F B De Waardvan Der Spek, P Van Neer
    Abstract:

    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.

  • 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
    British Journal of Dermatology, 2002
    Co-Authors: Lyn Guenther, P C M Van De Kerkhof, Knud Kragballe, F Cambazard, Erna Snellman, Eva Tegner, A Garciadiez, A C Chu, J Springborg
    Abstract:

    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. (Less)

  • the effect of addition of Calcipotriol ointment 50 micrograms g to acitretin therapy in psoriasis
    British Journal of Dermatology, 1998
    Co-Authors: P C M Van De Kerkhof, R J Damstra, P E Hutchinson, F Cambazard, E Haneke, E S Wong, P Souteyrand, P Combemale, M H A M Neumann, R J G Chalmers
    Abstract:

    Our purpose was to find out whether the addition of Calcipotriol ointment (50 micrograms/g) to systemic treatment with acitretin produces additional therapeutic effects and thereby an acitretin-sparing effect, and further to investigate the safety and tolerability of this combination. A multicentre, randomized, double-blind placebo-controlled study was designed. Patients were randomized to receive Calcipotriol or placebo. All patients were treated with a starting dose of 20 mg acitretin per day and doses were adjusted at 2-weekly intervals with increments of 10 mg per day up to a maximum of 70 mg per day. The dose requirement for acitretin, clinical signs and adverse events were recorded. Seventy-six patients were randomized to treatment with Calcipotriol 50 micrograms/g ointment twice daily and 59 patients to treatment with the vehicle only twice daily. Clearance or marked improvement was achieved by 67% of the patients in the Calcipotriol group and by 41% of the patients in the placebo group (P = 0.006). Calcipotriol treatment proved to have a statistically significant additional effect to acitretin on the Psoriasis Area and Severity Index, redness, thickness and scaliness as compared with placebo. Clearance or marked improvement was achieved with a statistically significantly lower cumulative dose of acitretin by the patients in the Calcipotriol group as compared with the placebo group. The number of patients reporting adverse events was pronounced and largely related to acitretin. No significant differences were observed between the two treatment groups with respect to adverse events. Laboratory assessments were essentially normal. The addition of Calcipotriol ointment to acitretin treatment contributes to the efficacy, reduces the cumulative dose of acitretin to reach marked improvement or clearance, and is well-tolerated and safe.

Knud Kragballe - One of the best experts on this subject based on the ideXlab platform.

  • quality of life in patients with scalp psoriasis treated with Calcipotriol betamethasone dipropionate scalp formulation a randomized controlled trial
    Journal of The European Academy of Dermatology and Venereology, 2009
    Co-Authors: Jean-paul Ortonne, Knud Kragballe, Jerry Tan, Cecilia Ganslandt, P. Nordin, Siegfried Segaert
    Abstract:

    Background  Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of Calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed. Objective  To assess the impact of treatment with either Calcipotriol plus betamethasone dipropionate scalp formulation or Calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups). Methods  This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (Calcipotriol 50 µg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol®, LEO Pharma A/S, Ballerup, Denmark) with twice-daily Calcipotriol scalp solution (50 µg/mL; Daivonex®, LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering ≥ 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16. Results  Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the Calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales. Conclusion  The two-compound scalp formulation was superior to Calcipotriol scalp solution in improving QoL in patients with scalp psoriasis. Conflict of interest declaration J.P. Ortonne has served as a paid speaker and consultant for LEO Pharma. C. Ganslandt is a salaried employee of LEO Pharma. J. Tan served as a speaker, investigator and advisory board member for LEO Pharma and received honoraria from LEO Pharma for these activities. P. Nordin served as a paid investigator for LEO Pharma in the clinical trial. K. Kragballe has served as a paid speaker and consultant for LEO Pharma. S. Segaert has served as a paid speaker, clinical investigator and consultant for LEO Pharma.

  • 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
    British Journal of Dermatology, 2009
    Co-Authors: Knud Kragballe, Jean-paul Ortonne, P. Nordin, V. Hoffmann, Siegfried Segaert
    Abstract:

    Summary 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.

  • a 52 week randomized safety study of a Calcipotriol betamethasone dipropionate two compound product dovobet daivobet taclonex in the treatment of psoriasis vulgaris
    British Journal of Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J Peyri
    Abstract:

    The Calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and Calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the Calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the Calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the Calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with Calcipotriol treatment.

  • a 52 week randomized safety study of a Calcipotriol betamethasone dipropionate two compound product dovobet daivobet taclonex in the treatment of psoriasis vulgaris
    British Journal of Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J Peyri
    Abstract:

    The Calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and Calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the Calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the Calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the Calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with Calcipotriol treatment.

  • efficacy results of a 52 week randomised double blind safety study of a Calcipotriol betamethasone dipropionate two compound product daivobet dovobet taclonex in the treatment of psoriasis vulgaris
    Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, Ziv Williams, Ake Svensson
    Abstract:

    Background: The Calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis. Objective: The primary objective was to investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks. The efficacy results are presented here. Methods: Six hundred and thirty-four patients were randomised double-blind to treatment (once daily, when required) with either: 52 weeks of two-compound product (two-compound group), 52 weeks of alternating 4-week periods of two-compound product and Calcipotriol (alternating group), or 4 weeks of two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Results: There was a trend towards a difference between treatments from the overall treatment effect for the percentage of satisfactory responses for each patient during the study (p = 0.071). This appeared to be due to the comparison of the two-compound and Calcipotriol groups (p = 0.025). Conclusion: There was a trend towards the efficacy of the two-compound product used for up to 52 weeks being better than that of 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol.

Siegfried Segaert - One of the best experts on this subject based on the ideXlab platform.

  • quality of life in patients with scalp psoriasis treated with Calcipotriol betamethasone dipropionate scalp formulation a randomized controlled trial
    Journal of The European Academy of Dermatology and Venereology, 2009
    Co-Authors: Jean-paul Ortonne, Knud Kragballe, Jerry Tan, Cecilia Ganslandt, P. Nordin, Siegfried Segaert
    Abstract:

    Background  Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of Calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed. Objective  To assess the impact of treatment with either Calcipotriol plus betamethasone dipropionate scalp formulation or Calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups). Methods  This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (Calcipotriol 50 µg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol®, LEO Pharma A/S, Ballerup, Denmark) with twice-daily Calcipotriol scalp solution (50 µg/mL; Daivonex®, LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering ≥ 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16. Results  Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the Calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales. Conclusion  The two-compound scalp formulation was superior to Calcipotriol scalp solution in improving QoL in patients with scalp psoriasis. Conflict of interest declaration J.P. Ortonne has served as a paid speaker and consultant for LEO Pharma. C. Ganslandt is a salaried employee of LEO Pharma. J. Tan served as a speaker, investigator and advisory board member for LEO Pharma and received honoraria from LEO Pharma for these activities. P. Nordin served as a paid investigator for LEO Pharma in the clinical trial. K. Kragballe has served as a paid speaker and consultant for LEO Pharma. S. Segaert has served as a paid speaker, clinical investigator and consultant for LEO Pharma.

  • 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
    British Journal of Dermatology, 2009
    Co-Authors: Knud Kragballe, Jean-paul Ortonne, P. Nordin, V. Hoffmann, Siegfried Segaert
    Abstract:

    Summary 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.

  • A new scalp formulation of Calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial
    British Journal of Dermatology, 2009
    Co-Authors: P C M Van De Kerkhof, Siegfried Segaert, V. Hoffmann, Alexander Vincent Anstey, L. Barnes, C. Bolduc, Kristian Reich, S. Saari, L. Vaillant
    Abstract:

    BACKGROUND: There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance. OBJECTIVES: To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol; LEO Pharma A/S, Ballerup, Denmark) containing Calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate), with the active ingredients as single compounds in the same vehicle. METHODS: This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (n = 568), betamethasone dipropionate 0.5 mg g(-1) (n = 563), or Calcipotriol 50 microg g(-1) (n = 286). The primary efficacy measure was the proportion of patients with 'absence of disease' or 'very mild disease' according to investigators' assessments at week 8. RESULTS: The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than the betamethasone dipropionate (61.0%, P = 0.0079) or Calcipotriol (43.4%, P < 0.0001) groups. The proportion of patients rating their scalp psoriasis as 'clear' or 'almost clear' was significantly higher for the two-compound scalp formulation (69.6%) than for betamethasone dipropionate (59.9%, P = 0.0006) or Calcipotriol (44.7%, P < 0.0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the Calcipotriol group. CONCLUSIONS: The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

F Cambazard - One of the best experts on this subject based on the ideXlab platform.

  • a 52 week randomized safety study of a Calcipotriol betamethasone dipropionate two compound product dovobet daivobet taclonex in the treatment of psoriasis vulgaris
    British Journal of Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J Peyri
    Abstract:

    The Calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and Calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the Calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the Calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the Calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with Calcipotriol treatment.

  • a 52 week randomized safety study of a Calcipotriol betamethasone dipropionate two compound product dovobet daivobet taclonex in the treatment of psoriasis vulgaris
    British Journal of Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J Peyri
    Abstract:

    The Calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and Calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the Calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the Calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the Calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with Calcipotriol treatment.

  • efficacy results of a 52 week randomised double blind safety study of a Calcipotriol betamethasone dipropionate two compound product daivobet dovobet taclonex in the treatment of psoriasis vulgaris
    Dermatology, 2006
    Co-Authors: Knud Kragballe, Joar Austad, F Cambazard, L. Barnes, C Fleming, A Bibby, M De La Brassinne, Hannele Heikkila, Ziv Williams, Ake Svensson
    Abstract:

    Background: The Calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis. Objective: The primary objective was to investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks. The efficacy results are presented here. Methods: Six hundred and thirty-four patients were randomised double-blind to treatment (once daily, when required) with either: 52 weeks of two-compound product (two-compound group), 52 weeks of alternating 4-week periods of two-compound product and Calcipotriol (alternating group), or 4 weeks of two-compound product followed by 48 weeks of Calcipotriol (Calcipotriol group). Results: There was a trend towards a difference between treatments from the overall treatment effect for the percentage of satisfactory responses for each patient during the study (p = 0.071). This appeared to be due to the comparison of the two-compound and Calcipotriol groups (p = 0.025). Conclusion: There was a trend towards the efficacy of the two-compound product used for up to 52 weeks being better than that of 4 weeks of the two-compound product followed by 48 weeks of Calcipotriol.

  • 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
    British Journal of Dermatology, 2002
    Co-Authors: Lyn Guenther, P C M Van De Kerkhof, Knud Kragballe, F Cambazard, Erna Snellman, Eva Tegner, A Garciadiez, A C Chu, J Springborg
    Abstract:

    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. (Less)

  • the effect of addition of Calcipotriol ointment 50 micrograms g to acitretin therapy in psoriasis
    British Journal of Dermatology, 1998
    Co-Authors: P C M Van De Kerkhof, R J Damstra, P E Hutchinson, F Cambazard, E Haneke, E S Wong, P Souteyrand, P Combemale, M H A M Neumann, R J G Chalmers
    Abstract:

    Our purpose was to find out whether the addition of Calcipotriol ointment (50 micrograms/g) to systemic treatment with acitretin produces additional therapeutic effects and thereby an acitretin-sparing effect, and further to investigate the safety and tolerability of this combination. A multicentre, randomized, double-blind placebo-controlled study was designed. Patients were randomized to receive Calcipotriol or placebo. All patients were treated with a starting dose of 20 mg acitretin per day and doses were adjusted at 2-weekly intervals with increments of 10 mg per day up to a maximum of 70 mg per day. The dose requirement for acitretin, clinical signs and adverse events were recorded. Seventy-six patients were randomized to treatment with Calcipotriol 50 micrograms/g ointment twice daily and 59 patients to treatment with the vehicle only twice daily. Clearance or marked improvement was achieved by 67% of the patients in the Calcipotriol group and by 41% of the patients in the placebo group (P = 0.006). Calcipotriol treatment proved to have a statistically significant additional effect to acitretin on the Psoriasis Area and Severity Index, redness, thickness and scaliness as compared with placebo. Clearance or marked improvement was achieved with a statistically significantly lower cumulative dose of acitretin by the patients in the Calcipotriol group as compared with the placebo group. The number of patients reporting adverse events was pronounced and largely related to acitretin. No significant differences were observed between the two treatment groups with respect to adverse events. Laboratory assessments were essentially normal. The addition of Calcipotriol ointment to acitretin treatment contributes to the efficacy, reduces the cumulative dose of acitretin to reach marked improvement or clearance, and is well-tolerated and safe.

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  • quality of life in patients with scalp psoriasis treated with Calcipotriol betamethasone dipropionate scalp formulation a randomized controlled trial
    Journal of The European Academy of Dermatology and Venereology, 2009
    Co-Authors: Jean-paul Ortonne, Knud Kragballe, Jerry Tan, Cecilia Ganslandt, P. Nordin, Siegfried Segaert
    Abstract:

    Background  Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of Calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed. Objective  To assess the impact of treatment with either Calcipotriol plus betamethasone dipropionate scalp formulation or Calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups). Methods  This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (Calcipotriol 50 µg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol®, LEO Pharma A/S, Ballerup, Denmark) with twice-daily Calcipotriol scalp solution (50 µg/mL; Daivonex®, LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering ≥ 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16. Results  Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the Calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales. Conclusion  The two-compound scalp formulation was superior to Calcipotriol scalp solution in improving QoL in patients with scalp psoriasis. Conflict of interest declaration J.P. Ortonne has served as a paid speaker and consultant for LEO Pharma. C. Ganslandt is a salaried employee of LEO Pharma. J. Tan served as a speaker, investigator and advisory board member for LEO Pharma and received honoraria from LEO Pharma for these activities. P. Nordin served as a paid investigator for LEO Pharma in the clinical trial. K. Kragballe has served as a paid speaker and consultant for LEO Pharma. S. Segaert has served as a paid speaker, clinical investigator and consultant for LEO Pharma.

  • 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
    British Journal of Dermatology, 2009
    Co-Authors: Knud Kragballe, Jean-paul Ortonne, P. Nordin, V. Hoffmann, Siegfried Segaert
    Abstract:

    Summary 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.

  • cost effectiveness of once daily treatment with Calcipotriol betamethasone dipropionate followed by Calcipotriol alone compared with tacalcitol in the treatment of psoriasis vulgaris
    Dermatology, 2005
    Co-Authors: Pascale Peeters, Jean-paul Ortonne, Rene Sitbon, Eric Guignard
    Abstract:

    Background: Daivobet® is a once-daily treatment of psoriasis vulgaris containing betamethasone dipropionate and Calcipotriol in a new ointment vehicle. Objective

  • comparative study of Calcipotriol mc 903 ointment and betamethasone 17 valerate ointment in patients with psoriasis vulgaris
    Journal of The American Academy of Dermatology, 1992
    Co-Authors: W J Cunliffe, J Berthjones, A Claudy, Geoffrey Fairiss, David Goldin, David Gratton, Catriona A Henderson, Colin A Holden, Stuart W Maddin, Jean-paul Ortonne
    Abstract:

    Background: Topical vitamin D analogues have been reported to be an effective treatment in patients with psoriasis. Comparative studies with existing treatments are required. Objective: Our purpose was to compare the effectiveness of Calcipotriol (50 μg/gm) and betamethasone 17-valerate (1 mg/gm) ointments twice daily in the treatment of stable plaque psoriasis. Methods: This study was a randomized, double-blind comparison over 6 weeks in 409 patients. Efficacy, as measured by the Psoriasis Area and Severity Index (PASI), and safety were assessed at 2, 4, and 6 weeks. Results: Reduction of PASI was statistically significant at all time points for both treatments but there were no significant between-treatment differences. At the completion of 6 weeks of treatment, the mean PASI reduction was 5.50 for Calcipotriol and 5.32 for betamethasone (95% confidence interval [CI] −0.40 to 0.78). Analysis of patient assessment at 6 weeks showed clearance or marked improvement in 61.2% of the Calcipotriol patients and 50.5% with betamethasone (95% CI 1.4 to 20.8). Calcipotriol produced significantly more local side effects (19.5% compared with 3.9%, p Conclusion: Calcipotriol ointment was as effective as betamethasone 17-valerate ointment as measured by the PASI and superior as measured by self-assessment in patients with stable plaque psoriasis. Both treatments were well tolerated.