Investigator's Global Assessment Score Research Articles

Replacing a Dopamine Agonist by the COMT-Inhibitor Tolcapone as an Adjunct to l-dopa in the Treatment of Parkinson's Disease

This study investigated the feasibility, safety, and potential benefit in motor symptom control when switching from a dopamine agonist to tolcapone as an adjunctive therapy in patients with Parkinson's disease with a fluctuating response to levodopa (l-dopa). We determined the efficacy of 2 replacement strategies. In this 10-week, randomized, open-label, stratified, parallel-group trial, 150 patients on a stable regimen of l-dopa/decarboxylase inhibitor in combination with bromocriptine, lisuride, or pergolide were switched to tolcapone. Primary end point was the change in daily "off" time from baseline to the end of week 10 as assessed by patient "on-off" diaries. Patients had their respective dopamine agonist reduced and finally withdrawn either by day 6 (short-term replacement, n = 72) or by day 23 (long-term replacement, n = 78). At week 10, a significant reduction from baseline in daily "off" time (-15.9 +/- 19.3%; P < 0.001) and a significant increase of "on" time (14.6 +/- 19.8%; P < 0.001) were observed. Other efficacy variables (Unified Parkinson's Disease Rating Scale II, III, and IVb and Investigator's Global Assessment scores) improved significantly after switching to tolcapone. In general, there was no significant difference between the 2 replacement strategies. Treatment was better tolerated after the switch to tolcapone according to the IGA of tolerability. Tolcapone, in principle, seems to be an alternative adjunct for patients, who fail to receive sufficient benefit from a dopamine agonist, for example, in case they do not tolerate an increase in dose or have unacceptable side effects. The switch from a dopamine agonist to tolcapone can be done safely within a few days.

Sodium L‐ascorbyl‐2‐phosphate 5% lotion for the treatment of acne vulgaris: a randomized, double‐blind, controlled trial

Antioxidants are becoming increasingly important in the treatment of skin disease. In addition to their known anti-inflammatory effects, antioxidants may act to prevent the oxidation of sebum which has been proposed to be comedogenic in acne patients. Sodium L-ascorbyl-2-phosphate (APS) is a stable vitamin C derivative and highly effective antioxidant that has demonstrated efficacy in acne in open label studies. To evaluate the efficacy and safety of APS 5% lotion for the treatment of acne in a blinded controlled study. A total of 50 subjects were randomized in a double-blind controlled trial to receive APS 5% lotion or vehicle for 12 weeks. Evaluation included an Investigator's Global Assessment Score, a Subjects' Global Assessment Score, lesion counts, cutaneous tolerability, and adverse events. APS 5% lotion demonstrated statistically significant improvement when compared to vehicle in all of the parameters measured. The adverse event frequency and cutaneous tolerability profile for APS 5% lotion were similar to vehicle. Adjunctive topical or oral agents and their impact on acne were not studied in this trial. This study demonstrates that 5% sodium L-ascorbyl-2-phosphate is efficacious as monotherapy for the treatment of acne. APS 5% lotion offers a novel addition to our current acne armamentarium.

An open-label study of the safety and efficacy of sertaconazole nitrate in the treatment of seborrheic dermatitis

To demonstrate the efficacy and evaluate the safety of sertaconazole nitrate cream 2% in the treatment of seborrheic dermatitis (SD).Single-center, open-label study.One academic medical center.Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.

Treatment with twice-weekly tacrolimus ointment in patients with moderate to severe atopic dermatitis: Results from two randomized, multicentre, comparative studies

Background: Twice-weekly tacrolimus ointment for mild to severe atopic dermatitis (AD) significantly reduced the number of flares and prolonged flare-free intervals compared with standard treatment in the CONTROL studies. Methods: Post hoc analysis of data from the CONTROL studies was carried out on patients with moderate to severe disease. Patients applied tacrolimus 0.1% (adults; n = 183) or 0.03% (children; n = 166) ointment twice-daily for ≤ 6 weeks to treat flares, entering the 12-month disease control period (DCP) when an Investigator Global Assessment (IGA) score of ≤ 2 was achieved. Patients were randomized to twice-weekly tacrolimus or vehicle ointment. Disease flares were treated with twice-daily tacrolimus ointment for 1–6 weeks until an IGA ≤ 2 was achieved. Results: Twice-weekly treatment significantly reduced the number of flares and time to first flare (p < 0.001). Around three times as many patients in each study had no flares of any severity throughout the double-blind period in the twice-weekly treatment group compared with the standard treatment group (p < 0.001). Improvements in symptoms and quality of life with twice-weekly treatment were above those observed with standard treatment. Twice-weekly treatment was well tolerated. Conclusions: A twice-weekly tacrolimus ointment regimen was effective in adults and children with moderate to severe AD.

Twice‐daily versus Once‐daily Applications of Pimecrolimus Cream 1% for the Prevention of Disease Relapse in Pediatric Patients with Atopic Dermatitis

The aim of this study is to compare twice-daily and once-daily applications of pimecrolimus cream 1% for prevention of atopic dermatitis relapses in pediatric patients. This multicenter trial enrolled 300 outpatients aged 2 to 17 years, with mild-to-severe atopic dermatitis. The patients were initially treated with twice-daily topical pimecrolimus until complete clearance or for up to 6 weeks (open-label period). Those who achieved a decrease of at least 1 point in the Investigator's Global Assessment score were then randomized to double-blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of disease remission (Investigator's Global Assessment = 0). The primary efficacy end point of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by Investigator's Global Assessment score > or = 3 and pruritus score > or = 2). Of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily (n = 134 in each group). The relapse rate was lower in the twice-daily dose group (9.9%) than that in the once-daily dose group (14.7%), but analysis of the time to disease relapse, using a Cox proportional model to adjust for confounding variables, did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31-1.30). Treatment of active atopic dermatitis lesions with pimecrolimus cream 1% twice daily, followed by the once-daily dosing regimen, was sufficient to prevent subsequent atopic dermatitis relapses over 16 weeks in pediatric patients.

Effect of balneotherapy on temporospatial gait characteristics of patients with osteoarthritis of the knee

Effects of balneotherapy on gait properties of patients with osteoarthritis of the knee were investigated prospectively. A total of 30 patients with knee osteoarthritis received balneotherapy consisting of two daily thermomineral water baths for 2 weeks. Patients were evaluated using gait analysis and clinical scores, both within 2 weeks, before and after spa treatment. Patients were walking faster in their control analyses (0.81 +/- 0.21 to 0.89 +/- 0.19 m/s; P = 0.017), with a shorter mean stance time (63.0 +/- 3.3 to 61.8 +/- 2.5% stride; P = 0.007), an increased cadence (96 +/- 13.1 to 100 +/- 11.9 steps/min; P = 0.094) and stride length (996 +/- 174 to 1,058 +/- 142 mm; P = 0.017). Balneotherapy also resulted in a significant decrease in Lequesne knee osteoarthritis index (12.1 +/- 3.7 to 10.0 +/- 3.3 points; P = 0.003), VAS for pain (58 +/- 25 to 33 +/- 15; P = 0.0001), VAS for patients' (56 +/- 24 to 29 +/- 19; P < 0.001) and investigator's global assessment (55 +/- 20 to 26 +/- 15; P < 0.0001) and WOMAC score (2.1 +/- 0.7 to 1.6 +/- 0.8; P = 0.0004). Balneotherapy has positive effects on gait properties and clinical health quality parameters of patients with knee osteoarthritis in short-term evaluations.

A double‐blind, randomized, vehicle‐controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIRTM) in the management of atopic dermatitis in paediatric patients

A multicenter, randomized, double-blind, vehicle-controlled clinical study was conducted to evaluate the efficacy and safety of MAS063DP in 60 paediatric patients affected by atopic dermatitis (AD), aged between 2 and 17 years. Using the Investigator's Global Assessment (IGA) score for AD, patients with a score of 2 (mild) or 3 (moderate) were enrolled in the study. Patients were randomly selected to receive MAS063DP (20 patients), MAS060 (20 patients, a similar formulation with lower key ingredients' concentration and no preservatives) or vehicle (20 patients).The study consisted in a treatment period of 43 days, with clinical evaluations at baseline (day 1), days 8, 15, 22, 29 and 43, at which time the treatment was stopped. MAS063DP showed nearly 80% improvement in IGA score at day 22, compared with 16.6% and 26.3% with the MAS060 and vehicle respectively. A statistically significant difference was found by comparing MAS063DP with MAS060 (p < 0.0001); a similar result was evidenced comparing MAS063DP and vehicle (p = 0.001). By contrast, no significant difference was found between MAS060 and vehicle. A statistically significant difference was sustained until the end of the study. MAS063DP may therefore be considered as one of the available regimens effective in the treatment of mild-to-moderate AD in children and adolescents.

Proactive disease management with 0·03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study

Long-term treatment for atopic dermatitis (AD) using low-dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent exacerbations. This 12-month, European, multicentre, randomized study investigated if proactive, twice-weekly application of 0.03% tacrolimus ointment can keep AD in remission and reduce the incidence of disease exacerbation (DE) in children. During the initial open-label period, 267 children with AD applied 0.03% tacrolimus ointment twice daily for up to 6 weeks to all affected areas. When an Investigator Global Assessment (IGA) score of <or=2 was achieved, the patient entered the disease control period (DCP) and was randomized to receive tacrolimus (n=125) or vehicle ointment (n=125) twice weekly for 12 months. Exacerbations were treated with 0.03% tacrolimus ointment twice daily until an IGA<or=2 was regained, then randomized treatment was restarted. The outcome measure was the number of DEs during the DCP that required substantial therapeutic intervention. Proactive application of 0.03% tacrolimus ointment significantly reduced the number of DEs during the DCP that required substantial therapeutic intervention (median difference: 1.0; P<0.001; Wilcoxon rank-sum test), the percentage of DE treatment days (median difference: 6.2; P<0.001; Wilcoxon rank-sum test), and increased the time to first DE requiring intervention (median: 173 vs. 38 days; P<0.001; stratified log-rank test). Differences in quality of life scores were not significant between groups. The adverse event profile was similar for both treatment approaches. Twice-weekly proactive application of 0.03% tacrolimus ointment over 12 months was effective for most paediatric study patients in preventing, delaying and reducing the occurrence of AD exacerbations.

Use of a Silklike Bedding Fabric in Patients with Atopic Dermatitis

Symptoms of atopic dermatitis are often affected by environmental irritants. Modulation of potential irritants may benefit such symptoms. The purpose of this study was to evaluate the impact of a novel silklike bedding fabric for persons with mild to moderate atopic dermatitis. Participants with mild to moderate atopic dermatitis were provided a bedsheet set. Eczema Area and Severity Index and Investigator Global Assessment were the primary outcome measures. Visual Analog Scale for itch and a quality of life were also evaluated. The Wilcoxon signed rank test indicated a significant decrease in severity, with the Investigator Global Assessment score decreasing from 2.05 to 1.74 at week 8 (p = 0.03), the Eczema Area and Severity Index decreasing from 2.63 at baseline to 2.19 (p = 0.014), and the itching score decreasing from 3.97 to 3.00 (p = 0.010). An increase in the study-specific quality of life index was also observed, changing from -0.08 (no change in quality of life) to 1.23 (some improvement) (p < 0.0001). Atopic dermatitis is commonly recalcitrant to therapy and synthetic silklike bed linens may have value as another option for the treatment of this disease. This pilot study demonstrated promising results that warrant confirmation in controlled clinical studies.

Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment

Long-term treatment for atopic dermatitis (AD) using low dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent relapses. This 12-month, European, multicentre, randomized study investigated whether the proactive use of 0.1% tacrolimus ointment applied twice weekly can keep AD in remission and reduce the incidence of disease exacerbations (DE). During the initial open-label period, 257 adults with AD applied 0.1% tacrolimus ointment twice daily (b.i.d.) for up to 6 weeks to affected areas. When an Investigator Global Assessment (IGA) score of <or=2 was achieved, the patient entered the disease control period (DCP) and was randomized to either proactive tacrolimus (n = 116) or vehicle ointment (n = 108) twice weekly for 12 months. Exacerbations were treated with 0.1% tacrolimus ointment b.i.d. until an IGA <or=2 was regained, then randomized treatment was restarted. The primary endpoint was the number of DEs during the DCP that required a substantial therapeutic intervention. Proactive tacrolimus 0.1% ointment application significantly reduced the number of DEs requiring substantial therapeutic intervention (median difference 2; P < 0.001; Wilcoxon rank sum test), the percentage of DE treatment days (median difference: 15.2%; P < 0.001; Wilcoxon rank sum test) and increased the time to first DE (median 142 vs 15 days; P < 0.001; stratified log-rank test). The adverse event profile was similar for the two treatment approaches. A 12-month, twice weekly proactive tacrolimus ointment application was an effective treatment in most study patients which prevented, delayed and reduced the occurrence of AD exacerbations

Clobetasol propionate emulsion formulation foam 0.05%: Review of phase II open-label and phase III randomized controlled trials in steroid-responsive dermatoses in adults and adolescents

Clobetasol propionate 0.05% emulsion foam was recently developed for use on multiple body sites. We sought to evaluate safety and efficacy of clobetasol emulsion foam 0.05% to treat steroid-responsive dermatoses in multiple age groups. A phase II open-label study evaluated the effect of clobetasol foam on the hypothalamic-pituitary-adrenal axis in 52 participants aged 6 years or older with mild-to-severe atopic dermatitis (AD). Cosyntropin stimulation test was used to determine the effect of clobetasol foam on hypothalamic-pituitary-adrenal axis, with a normal response considered to be a postinjection serum cortisol level greater than 18 mug/dL. Another phase II open-label pharmacokinetic safety study was conducted in 32 participants aged 12 years or older with mild-to-moderate plaque-type psoriasis. Pharmacokinetic parameters evaluated included maximal plasma concentration of clobetasol propionate, time to achieve maximum concentration, and area under the curve. Two phase III, randomized controlled studies assessed treatment success in participants aged 12 years or older with moderate-to-severe AD (N = 377) or mild-to-moderate plaque-type psoriasis (N = 497). In all studies, participants received study drug for 2 weeks. In the AD study, treatment success was determined using a composite end point requiring an Investigator's Static Global Assessment (ISGA) score of 0 or 1, erythema score of 0 or 1, induration/papulation score of 0 or 1, and improvement in the ISGA score of at least two grades from baseline. Likewise, the study in plaque-type psoriasis used a composite end point requiring an ISGA score of 0 or 1, erythema score of 0 or 1, scaling score of 0 or 1, plaque thickness score of 0, and improvement in the ISGA score of at least two grades from baseline. Significantly more participants achieved treatment success on clobetasol foam than vehicle foam (P < .0001 and P = .0005 for each study). Reversible hypothalamic-pituitary-adrenal axis suppression was observed in 27% of participants aged 18 years or older and 47% in participants aged between 6 and younger than 12 years, but 0% in participants aged between 12 and younger than 18 years. The studies evaluated short-term use only. Clobetasol emulsion formulation foam is safe and effective for treatment of moderate-to-severe AD and mild-to-moderate plaque-type psoriasis in patients aged 12 years or older.

Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment

Background: Long‐term treatment for atopic dermatitis (AD) using low dose, intermittent, topical anti‐inflammatory agents may control acute disease and prevent relapses. This 12‐month, European, multicentre, randomized study investigated whether the proactive use of 0.1% tacrolimus ointment applied twice weekly can keep AD in remission and reduce the incidence of disease exacerbations (DE).Methods: During the initial open‐label period, 257 adults with AD applied 0.1% tacrolimus ointment twice daily (b.i.d.) for up to 6 weeks to affected areas. When an Investigator Global Assessment (IGA) score of ≤2 was achieved, the patient entered the disease control period (DCP) and was randomized to either proactive tacrolimus (n = 116) or vehicle ointment (n = 108) twice weekly for 12 months. Exacerbations were treated with 0.1% tacrolimus ointment b.i.d. until an IGA ≤2 was regained, then randomized treatment was restarted. The primary endpoint was the number of DEs during the DCP that required a substantial therapeutic intervention.Results: Proactive tacrolimus 0.1% ointment application significantly reduced the number of DEs requiring substantial therapeutic intervention (median difference 2; P &lt; 0.001; Wilcoxon rank sum test), the percentage of DE treatment days (median difference: 15.2%; P &lt; 0.001; Wilcoxon rank sum test) and increased the time to first DE (median 142 vs 15 days; P &lt; 0.001; stratified log‐rank test). The adverse event profile was similar for the two treatment approaches.Conclusion: A 12‐month, twice weekly proactive tacrolimus ointment application was an effective treatment in most study patients which prevented, delayed and reduced the occurrence of AD exacerbations.

Reduction of relapses of atopic dermatitis with methylprednisolone aceponate cream twice weekly in addition to maintenance treatment with emollient: a multicentre, randomized, double-blind, controlled study

The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of active AD, but their long-term efficacy and potential to reduce or prevent relapses have only partially been addressed. To investigate long-term management (16 weeks) of AD with methylprednisolone aceponate (MPA) 0.1% cream twice weekly in addition to an emollient (Advabase((R))) after stabilization of an acute severe or very severe flare of AD with MPA cream. Patients > or = 12 years of age with a > or = 2-year history of moderate to severe AD were eligible for this multicentre, randomized, double-blind, controlled study if they presented with an acute flare of severe or very severe AD [Investigator's Global Assessment (IGA) score > or = 4]. After successful treatment of the flare in an acute phase (AP), patients received either MPA twice weekly plus emollient or emollient alone over a 16-week maintenance phase (MP). The primary study endpoint was time to relapse of AD. Secondary endpoints included relapse rate and disease status, the patient's assessment of intensity of itch, the Eczema Area and Severity Index, the IGA score, affected body surface area, Dermatology Life Quality Index (DLQI) and children's DLQI (CDLQI), patient's and investigator's global assessment of response and patient's assessment of quality of sleep. Two hundred and forty-nine patients entered the AP and 221 continued into the MP. Time to relapse was longer in the MPA group than in the emollient group. The probability of remaining free from relapse after 16 weeks was 87.1% in the MPA group compared with 65.8% for the emollient. Patients treated with MPA twice weekly had a 3.5-fold lower risk of experiencing a relapse than patients treated with emollient alone (hazard ratio 3.5, 95% confidence interval 1.9-6.4; P < 0.0001). MPA was also superior to emollient for all other efficacy endpoints. Therapy with both treatments was well tolerated. MPA twice weekly plus an emollient provides an effective maintenance treatment regimen to control AD. Once stabilized, treatment with MPA significantly reduces the risk of relapse and the intensity of itching, and improves the overall patient status.

Treatment of mild to moderate seborrhoeic dermatitis with MAS064D (Sebclair®), a novel topical medical device: results of a pilot, randomized, double‐blind, controlled trial

MAS064D (Sebclair) is a novel steroid-free cream containing multiple active ingredients. Objective of this pilot study was to evaluate the efficacy and safety of MAS064D in the treatment of mild to moderate SD of the face. Patients (n = 60) with SD were randomized to receive MAS064D (n = 40) or a matching vehicle (n = 20). The primary study endpoint was investigators' global assessment (IGA) score at day 28, compared with baseline. Secondary endpoints included: IGA score at day 14; investigators' assessment of erythema and scaling; patients' assessment of burning/stinging, pruritus and global response to MAS064D; resort to rescue medication; quality of life. Use of MAS064D for 4 weeks was associated with a higher percentage of success in the MAS064D group than in the vehicle group (approximately 68% vs 11%, P < 0.0001). The effects of MAS064D were significantly better than those of vehicle for investigator-assessed erythema and scaling, and patients' assessed pruritus and global response to MAS064D (P 0.01). No patient in the MAS064D group required rescue medication, compared with two patients in the vehicle group. Four patients (two each in the MAS064D and vehicle groups) reported a total of six non-serious adverse events. MAS064D appears to be an effective and well tolerated cream for the treatment of mild to moderate SD of the face. Further clinical evaluation of MAS064D in SD is warranted.

A randomized controlled trial of pimecrolimus cream 1% in adolescents and adults with head and neck atopic dermatitis and intolerant of, or dependent on, topical corticosteroids

There is a need for alternative treatments for atopic dermatitis (AD) of the face and neck as long-term use of topical corticosteroids (TCS) is associated with skin atrophy and telangiectasia and some patients develop allergy, intolerance or other side-effects. This study was designed to assess the efficacy and safety of pimecrolimus cream 1% in patients with AD of the face and neck who are either dependent on, or intolerant of, TCS. A 12-week study comprising a 6-week, double-blind, randomized, vehicle-controlled phase was conducted, followed by a 6-week, open-label phase. Two hundred patients aged 12 years or over with mild to moderate head and neck AD, intolerant of, or dependent on, TCS were randomized to either pimecrolimus cream or vehicle cream. The primary efficacy criterion was the facial investigator's global assessment score at 6 weeks. Secondary efficacy criteria were head and neck Eczema Area and Severity Index (EASI), pruritus score and eyelid dermatitis. Facial skin atrophy and telangiectasia were assessed with dermatoscopy. A significantly higher percentage of patients treated with pimecrolimus was cleared or almost cleared of facial AD compared with vehicle (47% vs. 16%, respectively). A statistically significant difference was also seen on head and neck EASI and pruritus score. Significantly more pimecrolimus-treated patients than vehicle-treated patients achieved clearance of eyelid dermatitis (45% vs. 19%, respectively). Among the 77 patients with skin atrophy at baseline, treatment with pimecrolimus was associated with a reversal in skin thinning. Of the 112 patients with telangiectasia at baseline, no statistically significant difference was seen between treatment groups. Adverse events occurred with similar frequency in both groups. Pimecrolimus cream 1% is effective in patients with head and neck dermatitis intolerant of, or dependent on, TCS. Reversion of skin atrophy may occur during TCS-free intervals.

Efficacy and safety of methylprednisolone aceponate ointment 0.1% compared to tacrolimus 0.03% in children and adolescents with an acute flare of severe atopic dermatitis

Topical glucocorticosteroids are the gold standard in treatment of atopic dermatitis (AD). Recently, topical calcineurin inhibitors have been developed for treatment of this condition. This study compared efficacy and safety of 0.1% methylprednisolone aceponate (MPA) ointment with 0.03% tacrolimus ointment for 3 weeks, in children and adolescents with severe to very severe flare of AD. The primary end point was treatment success, defined as a score of 'clear' or 'almost clear' in the static Investigator's Global Assessment (IGA) score. Secondary end points were the percentage change in the Eczema Area and Severity Index (EASI) and patients' assessment of itch and sleep, Children's Dermatology Life Quality Index, patient's assessment of global response, affected Body Surface Area and medication costs. 265 patients were randomized to either MPA (n = 129) or tacrolimus (n = 136) treatment, 257 patients completed the study. Methylprednisolone aceponate 0.1% ointment once daily provided rapid and relevant clinical benefit. Tacrolimus 0.03% ointment twice daily was equally effective with regard to success rate. Methylprednisolone aceponate was superior to tacrolimus for EASI, itch and sleep. Both treatments were well tolerated. Drug-related adverse events were only observed in the tacrolimus group. Medication costs were significantly lower for MPA. While both treatment groups showed similar efficacy results regarding treatment success (IGA), significant advantages were observed for EASI, itch and sleep with MPA 0.1%. These advantages and the significantly lower treatment costs highlight the benefits of MPA treatment, underlining its first-line role in treatment of children and adolescents with severe AD.

Treatment of Head and Neck Dermatitis with Ciclopiroxolamine Cream – Results of a Double-Blind, Placebo-Controlled Study

In atopic dermatitis, microbial allergens may be pathogenetically significant. Apart from Staphyloccocus aureus, these are primarily lipophilic Malassezia yeasts. They are particularly involved in the pathogenesis of head and neck dermatitis (HND), a special form of atopic dermatitis, which is often difficult to treat. Fifty patients (21 men, 29 women) with moderate to severe HND of at least 6 months’ duration were included in a prospective double-blind study. All of them showed at least 10% involvement of the head-neck region. The severity of disease was evaluated by Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI) for the head-neck region and a pruritus score. IgE antibodies to Malassezia sympodialis and/or Malassezia furfur (at least CAP class 1) were a prerequisite for study enrollment. Either 1% ciclopiroxolamine cream (Batrafen; Aventis Pharma, Bad Soden, Germany) or the corresponding base cream were thinly applied to the affected areas twice daily for 28 days. Sixteen patients in the ciclopiroxolamine group and 13 patients in the placebo group completed the study. To assess the change in severity of atopic eczema, IGA differences between the individual measuring points were determined for all patients. There were significant differences in the IGA score change between the ciclopiroxolamine group and the placebo group, from t₃ to t₄, and over the total period. Similar, but not significant, changes were observed with the EASI score, in terms of affected skin area and itching. The present study is the first to examine the effect of antifungal single-drug therapy with a cream containing ciclopiroxolamine on the course of HND. The study medication was found to be significantly effective. To optimize this effect, suitable patients selected in terms of fungal load, specific IgE, prick test and particularly atopy patch test for Malassezia antigens could receive combined treatment with antimycotic-containing shampoos and/ or short-term systemic antimycotic therapy in severe cases.

Cost Effectiveness of Management of Mild-to-Moderate Atopic Dermatitis with 1%??Pimecrolimus Cream in Children and Adolescents 2???17 Years of Age

Atopic dermatitis (AD) has the potential to cause a long-term economic impact on patients, their families, and the healthcare system. To determine if 1% pimecrolimus cream is cost-effective in treating mild-to-moderate AD in patients 2-17 years of age. Data on the efficacy of AD management with 1% pimecrolimus cream (Elidel, Novartis Pharma GmbH, Wehr, Germany) were obtained from a 12-month, randomized, double-blind, multinational, controlled clinical trial comparing pimecrolimus and conventional therapy. Markov modeling was used for the economic model, based on: (i) Investigator's Global Assessment scores assessed at each visit during the clinical trial; (ii) estimated costs for medication and physician visits for each level of disease severity; and (iii) utility values for each level of disease severity. The perspective was that of a third-party payer. In 2004 US dollars, the incremental cost-effectiveness of 1% pimecrolimus cream was 38,231 US dollars per quality-adjusted life year (QALY) gained compared with conventional therapy. Sensitivity analyses showed a range of 27,299 US dollarsto 63,457 US dollars per QALY gained. With an incremental cost-effectiveness ratio of <50,000 US dollars per QALY gained, 1% pimecrolimus cream offers a cost-effective therapeutic option in the management of AD.

Pimecrolimus and Tacrolimus for the Treatment of Intertriginous and Facial Psoriasis

Question 1: What is the response of intertriginous psoriasis to topicalpimecrolimus in comparisonwithvehicle? Design: Randomized, participantand outcome-evaluator– masked, vehicle-controlled trial. Setting: Industry-sponsored, multicenter study of patients recruited from medical school and hospital departments of dermatology. Patients: Adult patients with inverse psoriasis. Intervention: Twice-daily application of 1% pimecrolimus cream or vehicle. Main Outcome Measure: Percentage of patients reaching an investigator global assessment score of 0 (clear) or 1 (almost clear: mild erythema, no scaling, and no induration) by week 8 of treatment. A secondary outcome measure was the percentage of patients reaching a patient self-assessment score of 0 (complete disease control) or 1 (good disease control) by week 8 of treatment. Results: At week 8, 20 (71%) of 28 and 6 (21%) of 29 patients treated with pimecrolimus and vehicle, respectively, achieved an investigator global assessment of 0 or 1 (difference in response rate, 0.51; number needed to treat [NNT], 2) (Table). At week 8, 23 (82%) of 28 and 12 (41%) of 29 patients treated with pimecrolimus and vehicle, respectively, achieved a patient self-assessment score of 0 or 1 (difference in response rate, 0.41; NNT, 3) (Table). There were no serious adverse events, and no patient discontinued treatmentbecauseof adverseevents.Onepatient treated with pimecrolimus developed paresthesia.

Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: A double-blind, randomized study

Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.