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P C M Van De Kerkhof - One of the best experts on this subject based on the ideXlab platform.
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treatment of paediatric scalp psoriasis with calcipotriene Betamethasone Dipropionate scalp formulation effectiveness safety and influence on children s quality of life in daily practice
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: A M Oostveen, E.m.g.j. De Jong, P C M Van De Kerkhof, A.r.t. Donders, M M B SeygerAbstract:BACKGROUND: Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. OBJECTIVE: This study aims to evaluate the effectiveness and safety of calcipotriene/Betamethasone Dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. METHODS: Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). RESULTS: Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 +/- 11.8 to 12.7 +/- 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. CONCLUSION: In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/Betamethasone Dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.
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Treatment of paediatric scalp psoriasis with calcipotriene/Betamethasone Dipropionate scalp formulation: effectiveness, safety and influence on children's quality of life in daily practice.
Journal of the European Academy of Dermatology and Venereology, 2014Co-Authors: A M Oostveen, E.m.g.j. De Jong, P C M Van De Kerkhof, A.r.t. Donders, Marieke M.b. SeygerAbstract:BACKGROUND: Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. OBJECTIVE: This study aims to evaluate the effectiveness and safety of calcipotriene/Betamethasone Dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. METHODS: Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). RESULTS: Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 +/- 11.8 to 12.7 +/- 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. CONCLUSION: In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/Betamethasone Dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.
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calcipotriol Betamethasone Dipropionate ointment in mild to moderate paediatric psoriasis long term daily clinical practice data in a prospective cohort
British Journal of Dermatology, 2014Co-Authors: M Van Geel, E.m.g.j. De Jong, Karlien Mul, A M Oostveen, P C M Van De Kerkhof, M M B SeygerAbstract:BACKGROUND: Psoriasis in children has a significant negative impact on the quality of life (QoL) and effective treatment can improve this. The two-compound ointment calcipotriol 50 mug g(-1) and Betamethasone Dipropionate 0.5 mg g(-1) is an effective treatment option for moderate-to-severe psoriasis in adults. OBJECTIVES: To study prospectively the effectiveness and safety of calcipotriol/Betamethasone Dipropionate ointment in paediatric patients with mild-to-moderate plaque psoriasis in daily clinical practice and to investigate the influence on QoL. METHODS: Data were obtained from a prospective, longitudinal paediatric psoriasis registry, called Child-CAPTURE. Severity was assessed using the Psoriasis Area and Severity Index (PASI) and body surface area (BSA). The Children's Dermatology Life Quality Index (CDLQI) was used to assess QoL and visual analogue scores (VAS) for pain and itch were collected. For safety data the number of (serious) adverse events was recorded. RESULTS: Seventy-three patients (mean age 10.8 years, range 3-18) were treated for a median time of 35.0 weeks (range 1.0-176.0). At week 12, mean PASI decreased 15.4% (from 5.2 to 4.4), BSA barely changed, and median CDLQI decreased significantly from 5.5 to 4.0. VAS scores for pain and itch declined. At week 24, mean PASI decreased to 4.3 (17.3%). No related serious adverse events were observed. CONCLUSIONS: In this daily clinical practice study in paediatric psoriasis, calcipotriol/Betamethasone Dipropionate ointment initially improved mild-to-moderate psoriasis and then maintained its effect. In addition, it improved QoL, with few adverse events.
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pooled safety analysis of calcipotriol plus Betamethasone Dipropionate gel for the treatment of psoriasis on the body and scalp
Journal of The European Academy of Dermatology and Venereology, 2014Co-Authors: Knud Kragballe, P C M Van De KerkhofAbstract:The fixed combination calcipotriol plus Betamethasone Dipropionate gel is a first-line treatment for psoriasis vulgaris. The objective was to perform a large-scale assessment of tolerability of fixed combination gel (Cal/BD). Analysis was performed on pooled 8-week safety data from nine clinical trials evaluating once-daily Cal/BD treatment of scalp (n = 6) and body (n = 3) psoriasis. Pharmacovigilance data were also assessed. Patients were treated with Cal/BD [n = 1953 (scalp), n = 824 (body)], Betamethasone Dipropionate gel (BD; n = 1214, n = 562), calcipotriol gel (Cal; n = 979, n = 175), gel vehicle (VEH; n = 173, n = 226), calcipotriol scalp solution [n = 104 (scalp only)] and tacalcitol ointment [TAC; n = 184 (body only)]. Most adverse events (AEs) were mild-moderate severity. The proportion of scalp psoriasis patients with >/=1 AE was lowest with Cal/BD (35% versus 38-57%). A similar proportion was found with Cal/BD for body psoriasis (32%), however, lower proportions were reported with BD (24%) and Cal (29%). The most common AEs with Cal/BD included nasopharyngitis, pruritus and upper respiratory tract infection (2-5% of patients). Overall, only 5% of patients treated with Cal/BD reported >/=1 lesional/perilesional AEs: the lowest incidence versus scalp comparators (6-19%) and second lowest to BD (3%) for body psoriasis. Similarly, Cal/BD treatment resulted in the lowest incidence of >/=1 adverse drug reactions (ADRs) in scalp psoriasis patients (8% versus 9-27%) and second lowest to BD (6% versus 4%) for body psoriasis. Overall, incidence of serious AEs (SAEs) was low (0-1%). Data received postmarketing through spontaneous reporting revealed that SAEs reported more than once with Cal/BD treatment were psoriasis (n = 5); and alopecia, erythrodermic psoriasis, pruritus, skin atrophy and urticaria (n = 2 each). In this large subset of patients treated with Cal/BD, incidence of AEs and ADRs is consistently low. This analysis provides further evidence of the good tolerability of the fixed combination gel as treatment for psoriasis vulgaris.
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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, 2009Co-Authors: P C M Van De Kerkhof, Siegfried Segaert, V. Hoffmann, Alexander Vincent Anstey, L. Barnes, C. Bolduc, Kristian Reich, S. Saari, L. VaillantAbstract: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.
E.m.g.j. De Jong - One of the best experts on this subject based on the ideXlab platform.
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treatment of paediatric scalp psoriasis with calcipotriene Betamethasone Dipropionate scalp formulation effectiveness safety and influence on children s quality of life in daily practice
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: A M Oostveen, E.m.g.j. De Jong, P C M Van De Kerkhof, A.r.t. Donders, M M B SeygerAbstract:BACKGROUND: Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. OBJECTIVE: This study aims to evaluate the effectiveness and safety of calcipotriene/Betamethasone Dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. METHODS: Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). RESULTS: Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 +/- 11.8 to 12.7 +/- 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. CONCLUSION: In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/Betamethasone Dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.
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efficacy of a fixed combination of calcipotriol Betamethasone Dipropionate topical gel in adult patients with mild to moderate psoriasis blinded interim analysis of a phase iv multicenter randomized controlled prospective study
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: K Reich, E.m.g.j. De Jong, I Zschocke, H Bachelez, Paolo Gisondi, Lluis Puig, R B Warren, Ulrich MrowietzAbstract:BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/Betamethasone Dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/Betamethasone Dipropionate gel is highly efficacious and preferred by the majority of analysed patients.
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Treatment of paediatric scalp psoriasis with calcipotriene/Betamethasone Dipropionate scalp formulation: effectiveness, safety and influence on children's quality of life in daily practice
'Wiley', 2015Co-Authors: Oostveen A.m., E.m.g.j. De Jong, Kerkhof, P.c.m. Van De, Donders A.r.t., Seyger M.m.b.Abstract:Item does not contain fulltextBACKGROUND: Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. OBJECTIVE: This study aims to evaluate the effectiveness and safety of calcipotriene/Betamethasone Dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. METHODS: Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). RESULTS: Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 +/- 11.8 to 12.7 +/- 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. CONCLUSION: In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/Betamethasone Dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL
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Efficacy of a fixed combination of calcipotriol/Betamethasone Dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study
'Wiley', 2015Co-Authors: Reich K., E.m.g.j. De Jong, Bachelez H., Gisondi P., Puig L., Warren R.b., Mrowietz U., Group T.s.Abstract:BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/Betamethasone Dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/Betamethasone Dipropionate gel is highly efficacious and preferred by the majority of analysed patients
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Efficacy of a fixed combination of calcipotriol/Betamethasone Dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study
'Wiley', 2015Co-Authors: Reich K., E.m.g.j. De Jong, Bachelez H., Gisondi P., Puig L., Warren R.b., Mrowietz U., Group T.s.Abstract:Contains fulltext : 151852.pdf (Publisher’s version ) (Open Access)BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/Betamethasone Dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/Betamethasone Dipropionate gel is highly efficacious and preferred by the majority of analysed patients
Knud Kragballe - One of the best experts on this subject based on the ideXlab platform.
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pooled safety analysis of calcipotriol plus Betamethasone Dipropionate gel for the treatment of psoriasis on the body and scalp
Journal of The European Academy of Dermatology and Venereology, 2014Co-Authors: Knud Kragballe, P C M Van De KerkhofAbstract:The fixed combination calcipotriol plus Betamethasone Dipropionate gel is a first-line treatment for psoriasis vulgaris. The objective was to perform a large-scale assessment of tolerability of fixed combination gel (Cal/BD). Analysis was performed on pooled 8-week safety data from nine clinical trials evaluating once-daily Cal/BD treatment of scalp (n = 6) and body (n = 3) psoriasis. Pharmacovigilance data were also assessed. Patients were treated with Cal/BD [n = 1953 (scalp), n = 824 (body)], Betamethasone Dipropionate gel (BD; n = 1214, n = 562), calcipotriol gel (Cal; n = 979, n = 175), gel vehicle (VEH; n = 173, n = 226), calcipotriol scalp solution [n = 104 (scalp only)] and tacalcitol ointment [TAC; n = 184 (body only)]. Most adverse events (AEs) were mild-moderate severity. The proportion of scalp psoriasis patients with >/=1 AE was lowest with Cal/BD (35% versus 38-57%). A similar proportion was found with Cal/BD for body psoriasis (32%), however, lower proportions were reported with BD (24%) and Cal (29%). The most common AEs with Cal/BD included nasopharyngitis, pruritus and upper respiratory tract infection (2-5% of patients). Overall, only 5% of patients treated with Cal/BD reported >/=1 lesional/perilesional AEs: the lowest incidence versus scalp comparators (6-19%) and second lowest to BD (3%) for body psoriasis. Similarly, Cal/BD treatment resulted in the lowest incidence of >/=1 adverse drug reactions (ADRs) in scalp psoriasis patients (8% versus 9-27%) and second lowest to BD (6% versus 4%) for body psoriasis. Overall, incidence of serious AEs (SAEs) was low (0-1%). Data received postmarketing through spontaneous reporting revealed that SAEs reported more than once with Cal/BD treatment were psoriasis (n = 5); and alopecia, erythrodermic psoriasis, pruritus, skin atrophy and urticaria (n = 2 each). In this large subset of patients treated with Cal/BD, incidence of AEs and ADRs is consistently low. This analysis provides further evidence of the good tolerability of the fixed combination gel as treatment for psoriasis vulgaris.
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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, 2009Co-Authors: Jean-paul Ortonne, Knud Kragballe, Jerry Tan, Cecilia Ganslandt, P. Nordin, Siegfried SegaertAbstract: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.
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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, 2009Co-Authors: Knud Kragballe, Jean-paul Ortonne, P. Nordin, V. Hoffmann, Siegfried SegaertAbstract: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.
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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, 2006Co-Authors: Knud Kragballe, L. Barnes, C Fleming, F Cambazard, J Austad, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J PeyriAbstract: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.
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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, 2006Co-Authors: Knud Kragballe, L. Barnes, C Fleming, F Cambazard, J Austad, A Bibby, M De La Brassinne, Hannele Heikkila, D Jolliffe, J PeyriAbstract: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.
L. Vaillant - One of the best experts on this subject based on the ideXlab platform.
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Topical rapamycin versus Betamethasone Dipropionate ointment for treating oral erosive lichen planus: a randomized, double‐blind, controlled study
Journal of the European Academy of Dermatology and Venereology, 2020Co-Authors: Mahtab Samimi, A. Le Gouge, F. Boralevi, T. Passeron, F. Pascal, P. Bernard, S Agbo‐godeau, S. Leducq, Jc Fricain, L. VaillantAbstract:Background Although superpotent topical corticosteroids are the first-line treatment for oral erosive lichen planus (OELP), topical rapamycin was found efficient in a previous case series. Objectives To compare the efficacy and safety of topical rapamycin and Betamethasone Dipropionate ointment for OELP in a randomized, double-blind trial. Methods Patients were randomized to receive treatment with Betamethasone Dipropionate ointment 0.05% in Orabase(R) or topical rapamycin solution (1 mg/mL) on lesions twice daily for 3 months, followed by 3 months of observation. The primary outcome was clinical remission after 3 months of treatment. Secondary outcomes were clinical remission after 1 and 2 months, reduced oral pain and reduced impact on food intake after 3 months, clinical recurrence after treatment withdrawal, and adverse events. Results During a 4-year period, 76 patients were randomized and 75 received treatment (rapamycin, n = 39; Betamethasone, n = 36). At 3 months, 39.4% of patients with Betamethasone and 27.3% with rapamycin showed clinical remission (odds ratio 0.68, 95% CI [0.24; 1.89]; P = 0.46). Rates of remission after 1 and 2 months, reduction in pain and impact on food intake after 3 months, were higher with Betamethasone than rapamycin. Recurrence of oral erosions was similar between groups. Adverse events occurred in 43.6% of patients with rapamycin (mostly burning sensation, impaired taste) and 27.8% with Betamethasone (mostly oral candidiasis). Conclusion Although the study was limited by insufficient recruitment, we did not find any superiority of topical rapamycin over Betamethasone Dipropionate ointment for OELP. Given the rapid remission and pain improvement in the Betamethasone group, it appears that superpotent topical corticosteroids should remain the first-line treatment for OELP.
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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, 2009Co-Authors: P C M Van De Kerkhof, Siegfried Segaert, V. Hoffmann, Alexander Vincent Anstey, L. Barnes, C. Bolduc, Kristian Reich, S. Saari, L. VaillantAbstract: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.
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treatment of paediatric scalp psoriasis with calcipotriene Betamethasone Dipropionate scalp formulation effectiveness safety and influence on children s quality of life in daily practice
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: A M Oostveen, E.m.g.j. De Jong, P C M Van De Kerkhof, A.r.t. Donders, M M B SeygerAbstract:BACKGROUND: Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking. OBJECTIVE: This study aims to evaluate the effectiveness and safety of calcipotriene/Betamethasone Dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well. METHODS: Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP). RESULTS: Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 +/- 11.8 to 12.7 +/- 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months. CONCLUSION: In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/Betamethasone Dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.
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calcipotriol Betamethasone Dipropionate ointment in mild to moderate paediatric psoriasis long term daily clinical practice data in a prospective cohort
British Journal of Dermatology, 2014Co-Authors: M Van Geel, E.m.g.j. De Jong, Karlien Mul, A M Oostveen, P C M Van De Kerkhof, M M B SeygerAbstract:BACKGROUND: Psoriasis in children has a significant negative impact on the quality of life (QoL) and effective treatment can improve this. The two-compound ointment calcipotriol 50 mug g(-1) and Betamethasone Dipropionate 0.5 mg g(-1) is an effective treatment option for moderate-to-severe psoriasis in adults. OBJECTIVES: To study prospectively the effectiveness and safety of calcipotriol/Betamethasone Dipropionate ointment in paediatric patients with mild-to-moderate plaque psoriasis in daily clinical practice and to investigate the influence on QoL. METHODS: Data were obtained from a prospective, longitudinal paediatric psoriasis registry, called Child-CAPTURE. Severity was assessed using the Psoriasis Area and Severity Index (PASI) and body surface area (BSA). The Children's Dermatology Life Quality Index (CDLQI) was used to assess QoL and visual analogue scores (VAS) for pain and itch were collected. For safety data the number of (serious) adverse events was recorded. RESULTS: Seventy-three patients (mean age 10.8 years, range 3-18) were treated for a median time of 35.0 weeks (range 1.0-176.0). At week 12, mean PASI decreased 15.4% (from 5.2 to 4.4), BSA barely changed, and median CDLQI decreased significantly from 5.5 to 4.0. VAS scores for pain and itch declined. At week 24, mean PASI decreased to 4.3 (17.3%). No related serious adverse events were observed. CONCLUSIONS: In this daily clinical practice study in paediatric psoriasis, calcipotriol/Betamethasone Dipropionate ointment initially improved mild-to-moderate psoriasis and then maintained its effect. In addition, it improved QoL, with few adverse events.