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Matthias Brautigam - One of the best experts on this subject based on the ideXlab platform.
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gene expression is differently affected by Pimecrolimus and betamethasone in lesional skin of atopic dermatitis
Allergy, 2012Co-Authors: Jensmichael Jensen, Matthias Brautigam, Andreas Scherer, Christine Wanke, Sandrine Bongiovanni, Martin Letzkus, Frank Staedtler, Jeanne Kehren, M Zuehlsdorf, T SchwarzAbstract:To cite this article: Jensen JM, Scherer A, Wanke C, Brautigam M, Bongiovanni S, Letzkus M, Staedtler F, Kehren J, Zuehlsdorf M, Schwarz T, Weichenthal M, Folster-Holst R, Proksch E. Gene expression is differently affected by Pimecrolimus and betamethasone in lesional skin of atopic dermatitis. Allergy 2012; 67: 413–423. Abstract Background: Topical corticosteroids and calcineurin inhibitors are well-known treatments of atopic dermatitis (AD) but differ in their efficacy and side effects. We recently showed that betamethasone valerate (BM) although clinically more efficient impaired skin barrier repair in contrast to Pimecrolimus in AD. Objective: This study elucidates the mode of action of topical BM and Pimecrolimus cream in AD. Methods: Lesional AD skin samples after topical treatment with either BM or Pimecrolimus were subjected to gene expression profile analysis. Results: Betamethasone valerate resulted in a significant reduction in mRNA levels of genes encoding markers of immune cells and inflammation, dendritic cells, T cells, cytokines, chemokines, and serine proteases, whereas Pimecrolimus exerted minor effects only. This corroborates the clinical finding that BM reduces inflammation more effectively than Pimecrolimus. Genes encoding molecules important for skin barrier function were differently affected. Both BM and Pimecrolimus normalized the expression of filaggrin and loricrin. BM, but not Pimecrolimus, significantly reduced the expression of rate-limiting enzymes for lipid synthesis and the expression of involucrin and small proline-rich proteins, which covalently bind ceramides. This may explain the lack of restoration of functional stratum corneum layers observed after BM treatment. Conclusion: The gene expression profiles are consistent with our previous findings that corticosteroids may exert a more potent anti-inflammatory effect but may impair the restoration of the skin barrier. Corticosteroids are still the main treatment for severe and acutely exacerbated AD; Pimecrolimus may be preferable for long-term treatment and stabilization.
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different effects of Pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis
The Journal of Allergy and Clinical Immunology, 2009Co-Authors: Jensmichael Jensen, Matthias Brautigam, T Schwarz, Stephan Pfeiffer, Magdalena Witt, Claudia Neumann, Michael Weichenthal, Regina Folsterholst, Ehrhardt ProkschAbstract:Background Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. Objectives We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier. Methods In a randomized study 15 patients with AD were treated on one upper limb with Pimecrolimus and on the other with betamethasone twice daily for 3 weeks. Results Stratum corneum hydration and transepidermal water loss, a marker of the inside-outside barrier, improved in both groups. Dye penetration, a marker of the outside-inside barrier, was also reduced in both drugs. Electron microscopic evaluation of barrier structure displayed prevalently ordered stratum corneum lipid layers and regular lamellar body extrusion in Pimecrolimus-treated skin but inconsistent extracellular lipid bilayers and only partially filled lamellar bodies after betamethasone treatment. Both drugs normalized epidermal differentiation and reduced epidermal hyperproliferation. Betamethasone was superior in reducing clinical symptoms and epidermal proliferation; however, it led to epidermal thinning. Conclusion The present study demonstrates that both betamethasone and Pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because Pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.
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Pimecrolimus cream 1 in erosive oral lichen planus a prospective randomized double blind vehicle controlled study
British Journal of Dermatology, 2008Co-Authors: Thomas Volz, Matthias Brautigam, Ulrich M Caroli, H Ludtke, H Kohlerspath, Martin Rocken, Tilo BiedermannAbstract:Summary Background Erosive oral lichen planus (EOLP) is a T-cell mediated inflammatory disease leading to severe pain and impairment. As current therapies are of limited efficacy, application of calcineurin inhibitors is considered to be a potential option. Objectives To investigate the efficacy of Pimecrolimus cream 1% (Elidel®) compared with vehicle cream in the treatment of EOLP. Methods Twenty patients were enrolled in a prospective, double-blind, randomized, vehicle-controlled trial and assigned to either Pimecrolimus or vehicle group. Study medication was applied for 30 days followed by 30 days of observation without therapy. In case of unresponsiveness, treatment was continued for 30 days with open-label Pimecrolimus. EOLP was monitored on days 0, 30 and 60. Safety was assessed by patient documentation, measurement of Pimecrolimus levels and blood counts. Results Within 30 days erosions cleared completely in seven of 10 patients treated with Pimecrolimus and in two of 10 patients treated with vehicle. The clinical EOLP ‘composite score’ including mucosal erosions and pain sensation was significantly reduced in the Pimecrolimus-treated group compared with vehicle (P = 0·025). In the three of 10 patients not responding to Pimecrolimus, EOLP cleared after an additional 30 days of treatment with Pimecrolimus. Following termination of the therapy, sustained remission of EOLP was detected in 83% of patients demonstrating long-lasting effects of Pimecrolimus treatment. No severe adverse events were observed. In five patients Pimecrolimus blood levels were detected, all of which stayed below 4 ng mL−1. Conclusions Pimecrolimus cream 1% effectively treats EOLP with long-lasting therapeutic effects and is therefore a promising therapeutic option for EOLP.
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long term management of facial atopic eczema with Pimecrolimus cream 1 in paediatric patients with mild to moderate disease
Journal of The European Academy of Dermatology and Venereology, 2008Co-Authors: T Zuberbier, Matthias BrautigamAbstract:Background The aim of this post hoc analysis was to evaluate whether treatment of patients with atopic dermatitis (AD) with Pimecrolimus cream 1% can decrease the development of flares necessitating the use of a topical corticosteroid on the face and thus reduce the need for use of topical corticosteroids in this sensitive skin area. Patients and methods In a controlled, double-blind, multicentre study, 140 patients, aged 2 to 17 years, with facial involvement and mild to moderate disease after treatment of the initial flare with prednicarbate 0.25% cream were randomized to an intermittent treatment with Pimecrolimus cream 1% twice daily or vehicle for 24 weeks. If a flare occurred, defined as an exacerbation (unacceptable severity of itching/scratching or onset of oozing) not controlled by study medication, patients were treated with prednicarbate 0.25% cream instead. Results Patients in the vehicle group needed prednicarbate treatment on the face on 20.7% of the days vs. 11.7% of the study days in the Pimecrolimus group (P = 0.0024). Fifty per cent of patients in the Pimecrolimus group had no flare on the face during the treatment period compared with 37.5% of patients in the vehicle group (P = 0.012). The median time to first flare in Pimecrolimus-treated patients was twice as long as in patients receiving vehicle (138 vs. 68 days, P = 0.01). Three adverse events (one case of skin burning) suspected to be related to use of the study medication were reported for three patients (3.9%) in the Pimecrolimus group. Conclusion Long-term intermittent treatment of facial AD in children and adolescents with Pimecrolimus cream 1% does significantly reduce the need for topical corticosteroids.
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Pimecrolimus cream 1 efficacy in perioral dermatitis results of a randomized double blind vehicle controlled study in 40 patients
Journal of The European Academy of Dermatology and Venereology, 2007Co-Authors: T Oppel, Matthias Brautigam, T Pavicic, S Kamann, Andreas WollenbergAbstract:Background Perioral dermatitis (POD) is a common skin disease and difficult to treat. Pimecrolimus cream (1%) successfully controls atopic eczema. Objective Our aim was to investigate its efficacy in POD. Study design Single-centre, randomized, double-blind, vehicle-controlled study including 40 POD patients with a 4-week treatment and a 4-week follow-up. Efficacy was assessed by a novel Perioral Dermatitis Severity Index (PODSI) and Finlay's Dermatology Life Quality Index (DLQI). Setting Outpatient clinics of a large dermatological hospital in Munich, Germany. Results During treatment, the PODSI was significantly lower in the Pimecrolimus group compared with vehicle (P = 0.005–0.02) whereas at follow-up, no significant differences were observed. At week 2, the responder rates (≥ 50% PODSI improvement) were 50% with Pimecrolimus cream (1%) and 25% with vehicle (P = 0.095). DLQI was improved in Pimecrolimus group compared with vehicle. Conclusion Results suggest that Pimecrolimus cream (1%) effectively treats acute-stage POD.
Andreas Wollenberg - One of the best experts on this subject based on the ideXlab platform.
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a randomized double blind vehicle controlled study of 1 Pimecrolimus cream in adult patients with perioral dermatitis
Journal of The American Academy of Dermatology, 2008Co-Authors: T Schwarz, Thomas A. Luger, Torsten Zuberbier, Inga Kreiselmaier, Thomas Bieber, Diamant Thaci, Jan C Simon, Michael Meurer, T Werfel, Andreas WollenbergAbstract:Background Perioral dermatitis (POD) is a common dermatosis without standard therapy. Objective We sought to evaluate Pimecrolimus cream 1% in POD. Methods We conducted a multicenter, randomized, double-blind, parallel-group study in adult patients with POD treated twice daily with Pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment. Results Patients treated with Pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety. Limitations Pimecrolimus vehicle is not a true placebo. Conclusions Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.
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Pimecrolimus cream 1 efficacy in perioral dermatitis results of a randomized double blind vehicle controlled study in 40 patients
Journal of The European Academy of Dermatology and Venereology, 2007Co-Authors: T Oppel, Matthias Brautigam, T Pavicic, S Kamann, Andreas WollenbergAbstract:Background Perioral dermatitis (POD) is a common skin disease and difficult to treat. Pimecrolimus cream (1%) successfully controls atopic eczema. Objective Our aim was to investigate its efficacy in POD. Study design Single-centre, randomized, double-blind, vehicle-controlled study including 40 POD patients with a 4-week treatment and a 4-week follow-up. Efficacy was assessed by a novel Perioral Dermatitis Severity Index (PODSI) and Finlay's Dermatology Life Quality Index (DLQI). Setting Outpatient clinics of a large dermatological hospital in Munich, Germany. Results During treatment, the PODSI was significantly lower in the Pimecrolimus group compared with vehicle (P = 0.005–0.02) whereas at follow-up, no significant differences were observed. At week 2, the responder rates (≥ 50% PODSI improvement) were 50% with Pimecrolimus cream (1%) and 25% with vehicle (P = 0.095). DLQI was improved in Pimecrolimus group compared with vehicle. Conclusion Results suggest that Pimecrolimus cream (1%) effectively treats acute-stage POD.
Erin M Warshaw - One of the best experts on this subject based on the ideXlab platform.
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role of topical calcineurin inhibitors in the treatment of seborrheic dermatitis a review of pathophysiology safety and efficacy
American Journal of Clinical Dermatology, 2009Co-Authors: Bethany Cook, Erin M WarshawAbstract:Seborrheic dermatitis (SD) is characterized by erythematous pruritic patches and plaques with greasy scale that occur in sebaceous areas. It is common, affecting up to 3% of the population. Past treatments have relied on a wide variety of anti-inflammatory and antifungal agents, but corticosteroids have limited use because of long-term adverse effects. Topical calcineurin inhibitors provide a safe alternative for the treatment of SD, as these drugs block the inflammatory cascade involved in the disease process and pose no risk of skin atrophy. Studies of topical Pimecrolimus and tacrolimus in the treatment of SD have found that improvement occurred within 2 weeks, and if SD recurred after stopping treatment, it was significantly less severe. There have been no studies of the comparative efficacy of Pimecrolimus versus tacrolimus for the treatment of SD. Common adverse effects of mild burning and irritation have been associated with the use of both of these agents. Safety profile studies are limited to studies of atopic dermatitis, which show no increase in infection rate, photocarcinogenicity, or signs of immunosuppression in patients using topical calcineurin inhibitors for long-term treatment. This article reviews the clinical trials of Pimecrolimus and tacrolimus in the treatment of SD, focusing on efficacy and safety.
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results of a randomized double blind vehicle controlled efficacy trial of Pimecrolimus cream 1 for the treatment of moderate to severe facial seborrheic dermatitis
Journal of The American Academy of Dermatology, 2007Co-Authors: Erin M Warshaw, Ross Jon Wohlhuter, An Liu, Sarah A Zeller, Rachel Wenner, Sacharitha BowersAbstract:Background Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production. Objective We sought to compare the efficacy and safety of twice-daily Pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis. Methods This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to Pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations. Results In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 Pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for Pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [−0.195, 0.961]). Per protocol analysis (n = 41 Pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 Pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of Pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (Pimecrolimus = 26%; vehicle=12%). Limitations Generalizability is limited by the elderly male study population. Conclusion This study suggests that Pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.
Sacharitha Bowers - One of the best experts on this subject based on the ideXlab platform.
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results of a randomized double blind vehicle controlled efficacy trial of Pimecrolimus cream 1 for the treatment of moderate to severe facial seborrheic dermatitis
Journal of The American Academy of Dermatology, 2007Co-Authors: Erin M Warshaw, Ross Jon Wohlhuter, An Liu, Sarah A Zeller, Rachel Wenner, Sacharitha BowersAbstract:Background Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production. Objective We sought to compare the efficacy and safety of twice-daily Pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis. Methods This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to Pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations. Results In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 Pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for Pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [−0.195, 0.961]). Per protocol analysis (n = 41 Pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 Pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of Pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (Pimecrolimus = 26%; vehicle=12%). Limitations Generalizability is limited by the elderly male study population. Conclusion This study suggests that Pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.
T Schwarz - One of the best experts on this subject based on the ideXlab platform.
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gene expression is differently affected by Pimecrolimus and betamethasone in lesional skin of atopic dermatitis
Allergy, 2012Co-Authors: Jensmichael Jensen, Matthias Brautigam, Andreas Scherer, Christine Wanke, Sandrine Bongiovanni, Martin Letzkus, Frank Staedtler, Jeanne Kehren, M Zuehlsdorf, T SchwarzAbstract:To cite this article: Jensen JM, Scherer A, Wanke C, Brautigam M, Bongiovanni S, Letzkus M, Staedtler F, Kehren J, Zuehlsdorf M, Schwarz T, Weichenthal M, Folster-Holst R, Proksch E. Gene expression is differently affected by Pimecrolimus and betamethasone in lesional skin of atopic dermatitis. Allergy 2012; 67: 413–423. Abstract Background: Topical corticosteroids and calcineurin inhibitors are well-known treatments of atopic dermatitis (AD) but differ in their efficacy and side effects. We recently showed that betamethasone valerate (BM) although clinically more efficient impaired skin barrier repair in contrast to Pimecrolimus in AD. Objective: This study elucidates the mode of action of topical BM and Pimecrolimus cream in AD. Methods: Lesional AD skin samples after topical treatment with either BM or Pimecrolimus were subjected to gene expression profile analysis. Results: Betamethasone valerate resulted in a significant reduction in mRNA levels of genes encoding markers of immune cells and inflammation, dendritic cells, T cells, cytokines, chemokines, and serine proteases, whereas Pimecrolimus exerted minor effects only. This corroborates the clinical finding that BM reduces inflammation more effectively than Pimecrolimus. Genes encoding molecules important for skin barrier function were differently affected. Both BM and Pimecrolimus normalized the expression of filaggrin and loricrin. BM, but not Pimecrolimus, significantly reduced the expression of rate-limiting enzymes for lipid synthesis and the expression of involucrin and small proline-rich proteins, which covalently bind ceramides. This may explain the lack of restoration of functional stratum corneum layers observed after BM treatment. Conclusion: The gene expression profiles are consistent with our previous findings that corticosteroids may exert a more potent anti-inflammatory effect but may impair the restoration of the skin barrier. Corticosteroids are still the main treatment for severe and acutely exacerbated AD; Pimecrolimus may be preferable for long-term treatment and stabilization.
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different effects of Pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis
The Journal of Allergy and Clinical Immunology, 2009Co-Authors: Jensmichael Jensen, Matthias Brautigam, T Schwarz, Stephan Pfeiffer, Magdalena Witt, Claudia Neumann, Michael Weichenthal, Regina Folsterholst, Ehrhardt ProkschAbstract:Background Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. Objectives We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier. Methods In a randomized study 15 patients with AD were treated on one upper limb with Pimecrolimus and on the other with betamethasone twice daily for 3 weeks. Results Stratum corneum hydration and transepidermal water loss, a marker of the inside-outside barrier, improved in both groups. Dye penetration, a marker of the outside-inside barrier, was also reduced in both drugs. Electron microscopic evaluation of barrier structure displayed prevalently ordered stratum corneum lipid layers and regular lamellar body extrusion in Pimecrolimus-treated skin but inconsistent extracellular lipid bilayers and only partially filled lamellar bodies after betamethasone treatment. Both drugs normalized epidermal differentiation and reduced epidermal hyperproliferation. Betamethasone was superior in reducing clinical symptoms and epidermal proliferation; however, it led to epidermal thinning. Conclusion The present study demonstrates that both betamethasone and Pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because Pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.
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a randomized double blind vehicle controlled study of 1 Pimecrolimus cream in adult patients with perioral dermatitis
Journal of The American Academy of Dermatology, 2008Co-Authors: T Schwarz, Thomas A. Luger, Torsten Zuberbier, Inga Kreiselmaier, Thomas Bieber, Diamant Thaci, Jan C Simon, Michael Meurer, T Werfel, Andreas WollenbergAbstract:Background Perioral dermatitis (POD) is a common dermatosis without standard therapy. Objective We sought to evaluate Pimecrolimus cream 1% in POD. Methods We conducted a multicenter, randomized, double-blind, parallel-group study in adult patients with POD treated twice daily with Pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment. Results Patients treated with Pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety. Limitations Pimecrolimus vehicle is not a true placebo. Conclusions Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.