Bioavailability, Antipsoriatic Efficacy and Tolerability of a New Light Cream with Mometasone Furoate 0.1%

Mometasone furoate, a potent glucocorticoid (class III) with a favorable benefit/risk ratio, has emerged as a standard medication for the treatment of inflammatory skin disorders. The purpose of the investigation presented here was to determine the noninferiority of a topical mometasone formulation, a light cream (O/W 60/40 emulsion) with mometasone furoate 0.1% (water content of 33%) versus marketed comparators. Using the vasoconstrictor assay, a strong blanching effect of the new cream (called Mometasone cream) comparable to that of a mometasone comparator, a fatty cream with mometasone furoate 0.1%, could be demonstrated. Thus, the topical bioavailability of the active ingredient mometasone furoate (0.1%) was regarded to be similar for Mometasone cream and the mometasone comparator. Using the psoriasis plaque test, a strong antipsoriatic effect comparable to that of the mometasone comparator was found for Mometasone cream after 12 days of occlusive treatment. A nearly identical reduction in the mean infiltrate thickness and similar mean AUC values were noted with both formulations confirmed by clinical assessment data. The noninferiority of Mometasone cream to its active comparator with re-spect to the AUC of change to baseline in infiltrate thickness was demonstrated. Both medications were well tolerated. Overall, Mometasone cream and the mometasone comparator showed similar efficacy and tolerability. Mometasone cream, in addition to its high potency and good tolerability, provides the properties of a light cream, which might make this new medication particularly suitable for application on acutely inflamed and sensitive skin. Copyright (C) 2012 S. Karger AG, Base

Safety and efficacy of fluticasone propionate in the topical treatment of skin diseases

Fluticasone propionate - the first carbothioate corticosteroid - has been classified as a potent anti-inflammatory drug for dermatological use. It is available as 0.05% cream and 0.005% ointment formulations for the acute and maintenance treatment of patients with dermatological disorders such as atopic dermatitis, psoriasis and vitiligo. This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin. Although skin blanching following fluticasone propionate exceeds that of corticosteroids of medium strength, several clinical trials demonstrate a low potential for cutaneous and systemic side-effects, even in difficult-to-treat areas like the face, the eyelids and intertriginous areas. Even among paediatric patients with atopic dermatitis, fluticasone propionate proved to be safe and effective. These pharmacological and clinical properties are reflected by the high therapeutic index of this glucocorticoid

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research

Gastric Emphysema: An Etiologic Classification

I Gas within the wall of the stomach is a rare radiologic finding. The stomach has been the least often reported site of intramural gas in the hollow viscera. Based on etiology, gas in the wall of the stomach can be classified as either gastric emphysema or emphysematous gastritis. Gastric emphysema may be classified into traumatic, pulmonary or obstructive types depending upon the mechanism and pathogenesis. Three cases of gastric emphysema, each of different etiology, are presented to emphasize the subclassification of gastric emphysema. The clinical and prognostic significance of this classification is emphasized.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/72543/1/j.1440-1673.1984.tb02363.x.pd

Sensitivity to change of the Beach Questionnaire to behaviour, attitudes and knowledge related to sun exposure: quasi-experimental before-after study

Background: Health questionnaires must present accredited measurement properties such as validity, reliability and sensitivity to change, the latter being essential for interventions to be planned and for evaluating their effectiveness. The aim of this study was to evaluate the sensitivity to change of a Beach Questionnaire.Methods: Quasi-experimental before-after study carried out in 2011, for a study population of adolescents attending schools in the Costa del Sol. First, the questionnaire was administered to the adolescents, after which a multicomponent educational intervention was carried out; finally, three months later, the same questionnaire was re-administered to the same adolescents. Changes were assessed in the categories of each item, using the McNemar test, and the changes in the scores, standardised to a range of 0–100, using the Student t test for paired samples, and including the mean of the differences and the 95% confidence interval. The level of statistical significance was set at p < 0.05.Results: 228 adolescents, aged 14–17 years, and 55.3% were girls. Statistically significant changes were observed in sunburn experiences, exposure to the sun at mid-day and attitudes to sun exposure and suncreams. For the seven items related to knowledge about sun exposure, a higher rate of correct answers was observed. The analysis of changes, within the standardised range, revealed a significant improvement in the scores for sun exposure habits (MD 4.33; CI 95% 2.2-6.5), attitudes to sun exposure (MD 2.22; CI 95% 1.2-3.2) and knowledge (MD 9.10; CI 95% 7.1-11.1), but not in those for sun-protection practices (MD 0.23; CI 95% -1.2-1.7).Conclusions: The Beach Questionnaire on behaviour, attitudes and knowledge related to sun exposure is the first such instrument in Spanish language to provide sufficient sensitivity to change. It constitutes a useful tool for epidemiologic research into photoprotection and for skin cancer prevention programmes.The authors would like to acknowledge support from the Research Department of the Costa del Sol Hospital

Health-related quality of life of patients following selected types of lumbar spinal surgery: A pilot study

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Large-Scale Phenotyping of an Accurate Genetic Mouse Model of JNCL Identifies Novel Early Pathology Outside the Central Nervous System

Cln3Δex7/8 mice harbor the most common genetic defect causing juvenile neuronal ceroid lipofuscinosis (JNCL), an autosomal recessive disease involving seizures, visual, motor and cognitive decline, and premature death. Here, to more thoroughly investigate the manifestations of the common JNCL mutation, we performed a broad phenotyping study of Cln3Δex7/8 mice. Homozygous Cln3Δex7/8 mice, congenic on a C57BL/6N background, displayed subtle deficits in sensory and motor tasks at 10–14 weeks of age. Homozygous Cln3Δex7/8 mice also displayed electroretinographic changes reflecting cone function deficits past 5 months of age and a progressive decline of retinal post-receptoral function. Metabolic analysis revealed increases in rectal body temperature and minimum oxygen consumption in 12–13 week old homozygous Cln3Δex7/8mice, which were also seen to a lesser extent in heterozygous Cln3Δex7/8 mice. Heart weight was slightly increased at 20 weeks of age, but no significant differences were observed in cardiac function in young adults. In a comprehensive blood analysis at 15–16 weeks of age, serum ferritin concentrations, mean corpuscular volume of red blood cells (MCV), and reticulocyte counts were reproducibly increased in homozygous Cln3Δex7/8 mice, and male homozygotes had a relative T-cell deficiency, suggesting alterations in hematopoiesis. Finally, consistent with findings in JNCL patients, vacuolated peripheral blood lymphocytes were observed in homozygous Cln3Δex7/8 neonates, and to a greater extent in older animals. Early onset, severe vacuolation in clear cells of the epididymis of male homozygous Cln3Δex7/8 mice was also observed. These data highlight additional organ systems in which to study CLN3 function, and early phenotypes have been established in homozygous Cln3Δex7/8 mice that merit further study for JNCL biomarker development