An open-label adrenal suppression study of 0.1% fluocinonide cream in pediatric patients with atopic dermatitis

OBJECTIVE: To assess the potential of a superhigh-potency 0.1% fluocinonide cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis in pediatric patients with atopic dermatitis. DESIGN: A multicenter, multiple-dose, open-label safety study in 4 age cohorts with 0.1% fluocinonide cream applied once or twice daily for 2 weeks. SETTING: Clinical outpatient setting. PATIENTS: Patients with moderate to severe atopic dermatitis with 20% or more of the body surface area involved were included in the study. Each cohort began only after evaluation of the preceding cohort: ages 12 to younger than 18 years (cohort 1); 6 to younger than 12 years (cohort 2); 2 to younger than 6 years (cohort 3); and 3 months to younger than 2 years (cohort 4). MAIN OUTCOME MEASURES: Assessment of HPA axis suppression, local and systemic adverse events, and change in disease status from baseline. RESULTS: Suppression of the HPA axis was not observed in any patient treated once daily for the 2 youngest cohorts. Suppression was observed in 1 (7%) of 15 and 2 (12%) of 16 patients in the fluocinonide twice-daily group in cohorts 1 and 2, respectively. In all 4 cohorts, more than 90% of patients in the fluocinonide once-daily and twice-daily groups showed improvement in their disease status. CONCLUSIONS: Once-daily treatment with 0.1% fluocinonide cream for 2 weeks does not result in HPA axis suppression under the conditions of this study. Once-daily applications provided similar or better efficacy as twice-daily applications with a lower risk of HPA axis suppression. The frequency of HPA axis suppression is no greater in younger children than in older children. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN71227633.     

First image from a combined positron emission tomography and field‐cycled MRI system

Combining positron emission tomography and MRI modalities typically requires using either conventional MRI with a MR‐compatible positron emission tomography system or a modified MR system with conventional positron emission tomography. A feature of field‐cycled MRI is that all magnetic fields can be turned off rapidly, enabling the use of conventional positron emission tomography detectors based on photomultiplier tubes. In this demonstration, two photomultiplier tube‐based positron emission tomography detectors were integrated with a field‐cycled MRI system (0.3 T/4 MHz) by placing them into a 9‐cm axial gap. A positron emission tomography‐MRI phantom consisting of a triangular arrangement of positron‐emitting point sources embedded in an onion was imaged in a repeating interleaved sequence of ～1 sec MRI then 1 sec positron emission tomography. The first multimodality images from the combined positron emission tomography and field‐cycled MRI system show no additional artifacts due to interaction between the systems and demonstrate the potential of this approach to combining positron emission tomography and MRI. Magn Reson Med, 2011. © 2011 Wiley‐Liss, Inc.     

Feeling,caring, knowing: different types of empathy deficit in boys with psychopathic tendencies and autism spectrum disorder

Background: Empathy dysfunction is one of the hallmarks of psychopathy, but it is also sometimes thought to characterise autism spectrum disorders (ASD). Individuals with either condition can appear uncaring towards others. This study set out to compare and contrast directly boys with psychopathic tendencies and boys with ASD on tasks assessing aspects of affective empathy and cognitive perspective taking. The main aim of the study was to assess whether a distinct profile of empathy deficits would emerge for boys with psychopathic tendencies and ASD, and whether empathy deficits would be associated with conduct problems in general, rather than psychopathic tendencies or ASD specifically. Methods: Four groups of boys aged between 9 and 16 years (N = 96) were compared: 1) psychopathic tendencies, 2) ASD, 3) conduct problems and 4) comparison. Tasks were included to probe attribution of emotions to self, empathy for victims of aggression and cognitive perspective‐taking ability. Results: Boys with psychopathic tendencies had a profile consistent with dysfunctional affective empathy. They reported experiencing less fear and less empathy for victims of aggression than comparison boys. Their cognitive perspective‐taking abilities were not statistically significantly different from those of comparison boys. In contrast, boys with ASD had difficulties with tasks requiring cognitive perspective taking, but reported emotional experiences and victim empathy that were in line with comparison boys. Boys with conduct problems did not differ from comparison boys, suggesting that the affective empathy deficit seen in boys with psychopathic tendencies was specific to that group, rather than common to all boys with conduct problems. Conclusions: Although both groups can appear uncaring, our findings suggest that the affective/information processing correlates of psychopathic tendencies and ASD are quite different. Psychopathic tendencies are associated with difficulties in resonating with other people’s distress, whereas ASD is characterised by difficulties in knowing what other people think.     

A multicenter,double-blind,randomized, placebo-controlled study of rifaximin for the treatment of bacterial vaginosis

ObjectiveTo compare efficacy and tolerability between different regimens of rifaximin vaginal tablets and a placebo for treatment of bacterial vaginosis.MethodsIn a prospective study carried out at 13 sites in 3 European countries between August 2009 and October 2010, White, non-pregnant, premenopausal women with bacterial vaginosis were randomly assigned to receive rifaximin at 100 mg for 5 days (100 mg/5 days), 25 mg/5 days, or 100 mg/2 days, or placebo. Women were assessed at 7–10 and 28–35 days. Diagnosis and cure were based on Amsel criteria and Nugent score. Fisher exact test was used to compare cure rates.ResultsAmong 114 women recruited, 103 were evaluable for drug efficacy. Therapeutic cure rate at first follow-up was higher in the rifaximin 25 mg/5 days (48%, P = 0.04), 100 mg/2 days (36.0%), and 100 mg/5 days (25.9%) groups than in the placebo group (19.0%). At second follow-up, therapeutic cure rate was 28.0%, 14.8%, and 4.0% in the respective groups versus 7.7% in the placebo group. No difference in adverse events was observed.ConclusionRifaximin at 25 mg/5 days showed better therapeutic cure rates and maintenance of therapeutic cure after 1 month versus placebo. All treatment regimens were well tolerated.EudraCT number: 2009-011826-32.