A phase i study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates

Background

Defects in skin barrier function are associated with an increase risk of eczema and atopic sensitisation. Ceramide-dominant triple lipid mixture may improve and maintain the infant skin barrier function, and if shown to be safe and feasible, may therefore offer an effective approach to reduce the incidence of eczema and subsequent atopic sensitisation. We sort to assess the safety and compliance with daily application of a ceramide-dominant triple lipid formula (EpiCeram?) commencing in the neonatal period for the prevention of eczema.

Methods

Ten infants (0-4 weeks of age) with a family history of allergic disease were recruited into an open-label, phase one trial of daily application of EpiCeram? for six weeks. The primary outcomes were rate of compliance and adverse events. Data on development of eczema, and physiological properties of the skin (transepidermal water loss, hydration, and surface pH) were also measured.

Results

Eighty percent (8/10) of mothers applied the study cream on 80% or more of days during the six week intervention period. Though a number of adverse events unrelated to study product were reported, there were no adverse skin reactions to the study cream.

Conclusions

These preliminary results support the safety and parental compliance with daily applications of a ceramide-dominant formula for the prevention of eczema, providing the necessary ground work for a randomised clinical trial to evaluate EpiCeram? for the prevention of eczema.

Trial registration

The study was listed at the Australian/New Zealand Clinical Trial Registry (ANZCTR): reg. no. ACTRN12609000727246.     

Migraine preventive medications: a reappraisal

Newer acute care migraine medications demonstrate improved rapidity of action, consistent effectiveness, excellent safety profiles, and rarely cause rebound headaches. Their use could decrease the need for migraine-preventive medication. The present analysis derives a formula that can be used by practitioners to determine the cost-effectiveness of various migraine-preventive medications relative to selected acute-care medications. We propose a measure called the cost-equivalent number (CEN), the number of headaches per month at which the cost of the preventive medication equals the cost savings in acute-care treatment realized by using the preventive medication. The use of the CEN individualizes the decision of whether to use a migraine-preventive medication, weighing both the efficacy and cost of the preventive medication against the cost of the acute-care medication. A CEN lower than the migraine frequency suggests that use of a preventive medication will be cost-effective.     

No association between serum eosinophil cationic protein and atopic dermatitis or allergic rhinitis in an unselected population of children

Background In order to obtain background references when dealing with serum eosinophil cationic protein (s‐ECP) measurements in children with allergic diseases, population‐based studies are important. The objectives of our study were to explore the strength of associations between the s‐ECP level and atopic dermatitis (AD), allergic rhinitis (AR) and asthma in an unselected northern Norwegian schoolchildren population. Methods s‐ECP was sampled from 396 schoolchildren aged 7–12 years from Sør‐Varanger community, northern Norway as a part of a population‐based study of allergy. In advance, anamnestic information concerning a history of AD, AR and asthma were obtained. The children underwent a clinical investigation, including skin prick tests and peak expiratory flow measurements, where the presence of AD, AR and asthma were evaluated. The associations of these diseases to the s‐ECP values were examined in bivariate statistical analysis. Results No statistical significant associations were detected in bivariate analysis between s‐ECP and AD, AR or asthma: the mean s‐ECP in children without self‐reported AD/AR/asthma was 4.6 µg/L [95% confidence interval (CI) 4.0–5.2]. The mean s‐ECP in children with self‐reported AD or AR or asthma was 5.2 µg/L (95% CI 4.1–6.2), 4.6 µg/L (95% CI 3.5–5.7) and 6.4 µg/L (95% CI 4.4–8.3), respectively. The highest mean s‐ECP level was measured in children with clinically diagnosed asthma; 7.1 µg/L (95% CI 4.0–10.3). Above the 75‐percentile level of s‐ECP, only 17.2% of the children had a history of asthma. Conclusions In this unselected children population, the occurrence of AD or AR was not reflected by an increase in the s‐ECP level. The s‐ECP was increased in children with asthma, but was not statistically significant. Furthermore, the majority of children with high s‐ECP values were not asthmatics. We conclude that the associations between s‐ECP and allergic diseases are weak in an unselected population of children.     

Anandamide modulates the neuroendocrine responses induced by extracellular volume expansion

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