Efficacy and Patient-Reported Outcomes of a New Mometasone Cream Treating Atopic Eczema

This double-blind controlled phase II study was conducted to compare a newly developed formulation of mometasone furoate with a water content of 33% (Monovo (R) Cream) and with a smooth consistency versus the commercially available fatty cream of mometasone furoate (Ecural (R) Fettcreme) in terms of efficacy, cosmetic properties, and patients' acceptance. In 20 patients with mild to moderate atopic eczema, the preparations were tested intraindividually in a randomized mode and in two comparable lesion areas. Both preparations were equally effective and well tolerated. Due to improved cosmetic properties, the new formulation was preferred by the patients when asked for preferential use. Quality of life could be improved by treating with both preparations. Copyright (C) 2012 S. Karger AG, Base

Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention

BackgroundAtopic dermatitis (atopic eczema) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence. Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on disease prevention, with limited success. Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization.ObjectiveOur objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates.MethodsWe performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis. Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth. Parents in the control arm were asked to use no emollients. The primary feasibility outcome was the percentage of families willing to be randomized. The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months, as assessed by a trained investigator.ResultsForty-two percent of eligible families agreed to be randomized into the trial. All participating families in the intervention arm found the intervention acceptable. A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50% (relative risk, 0.50; 95% CI, 0.28-0.9; P = .017). There were no emollient-related adverse events and no differences in adverse events between groups.ConclusionThe results of this trial demonstrate that emollient therapy from birth represents a feasible, safe, and effective approach for atopic dermatitis prevention. If confirmed in larger trials, emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases

Induction of a hardening phenomenon by repeated application of SLS: analysis of lipid changes in the stratum corneum

Adaptation of the skin to repeated influence of exogenous irritants is called the hardening phenomenon. We investigated the stratum corneum lipid composition before and after induction of a hardening phenomenon. Irritant contact dermatitis was induced in 23 non-atopic volunteers by repeated occlusive application of 0.5% sodium lauryl sulfate (SLS) over 3 weeks. At 3, 6 and 9 weeks after irritation, the SLS responses of pre-irritated skin and normal skin were compared. The horny layer lipid composition (ceramides 1–7, cholesterol and free fatty acids) was assessed before irritation and 3, 6 and 9 weeks after irritation. During the first 2 weeks of irritation the transepidermal water loss increased continuously and seemed to decrease during the third week (effect of adaptation). The barrier function of pre-irritated sites was more stable to SLS challenge. Three weeks after irritation, there was a significant increase of ceramide 1 (pv0. 001). The only volunteer without hardening phenomenon showed no increase of ceramide 1. Ceramide 1 seems to play a key role as a protection mechanism against repeated irritation. Key words: hardening phenomenon; irritant contact dermatitis; stratum corneum lipids; ceramides; transepidermal water loss

Efficacy of a Tyrothricin-Containing Wound Gel in an Abrasive Wound Model for Superficial Wounds

Background: Topical preparations are a common treatment for superficialacute wounds, which at the least do not interfere with healing andideally result in enhanced wound healing irrespective of microbialcolonization. Objective: To examine the effects of a topicalantimicrobial gel and its vehicle on the wound healing of standardized,superficial abrasions. Methods: Thirty-three healthy volunteers wereenrolled in a double-blinded, randomized, intraindividual comparisonstudy. Three standardized, superficial abrasions were induced on theirforearms. A tyrothricin 0.1% gel (Tyrosur (R) gel; EngelhardArzneimittel GmbH & Co. KG, Niederdorfelden, Germany) and its vehiclewere randomly applied to two of the test areas, and one lesion remaineduntreated. Results: A significant improvement of wound healing was seenwith both tyrothricin 0.1% gel and its corresponding vehicle in theclinical assessment. The mean area under the curve (AUC) of woundhealing scores was the same for both preparations and the meanreepithelization scores were comparable at all test points over theentire 12 days. A lower mean AUC representing less reepithelization wasfound for the untreated test fields. Conclusion: The use of tyrothricin0.1% gel and its corresponding vehicle resulted in statisticallysignificant improved wound healing with an earlier onset of healing inparticular. Based on these results obtained using an abrasive woundmodel, it can be concluded that the addition of tyrothricin 0.1% to thegel vehicle did not interfere with the improved wound healing seen withthe vehicle alone

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

Scientific opinion on the safety of monacolins in red yeast rice

The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of monacolins in red yeast rice (RYR) and to provide advice on a dietary intake of monacolins that does not give rise to concerns about harmful effects to health. The Panel reviewed the scientific evidences available as well as the information provided by interested parties in response of a public ‘Call for data’ launched by EFSA. The Panel considered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. On the basis of the information available, the Panel concluded that intake of monacolins from RYR via food supplements, could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The Panel considered that the available information on the adverse effects reported in humans were judged to be sufficient to conclude that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day. The Panel further considered that individual cases of severe adverse reactions have been reported for monacolins from RYR at intake levels as low as 3 mg/day. The Panel concluded that exposure to monacolin K from RYR could lead to severe adverse effects on musculoskeletal system, including rhabdomyolysis, and on the liver. In the reported cases, the product contained other ingredients in addition to RYR. However, these reported effects in particular musculoskeletal effects, have both occurred after ingestion of monacolin K and lovastatin independently. On the basis of the information available and several uncertainties highlighted in this opinion, the Panel was unable to identify a dietary intake of monacolins from RYR that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population

Evidence-Based Management of Hand Eczema

Hand eczema is a common skin disease with a wide variation in morphology and a complex etiology based on endogenous and exogenous factors.The diagnosis of hand eczema is based on patient history, exposure assessment, physical examination, and the results of patch testing. Management of hand eczema starts with education of the patient on the etiology of the disease, and the needed changes in behavior regarding skin care and preventive measures, and avoidance of relevant exposure factors. In many cases, medical treatment is needed for successful management of the disease; use of medication can only be successful with proper education and avoidance of relevant exposure