A New Moisturiser Improves DNCB-induced Atopic Dermatitis-like Symptoms and Restores Skin Barrier Function in BALB/c Mice.

INTRODUCTION: Atopic dermatitis (AD) is a chronic, inflammatory skin disorder with eczematous and pruritic lesions. Topical moisturisers and either topical corticosteroids or calcineurin inhibitors are usually recommended. Restoring the skin barrier function alleviates AD symptoms. OBJECTIVE: To evaluate the efficacy of a new moisturiser compared to commercially available products in an AD murine model. METHODS: Experimental AD was induced with topical applications of 2,4-DiNitroChloroBenzene (DNCB) on the shaved back skin of BALB/c mice from Day 1 to Day 38. Mice were randomized to either Vehicle/-, DNCB/-, or DNCB/Eczekalm (test product), DNCB/Atopiclair®, or DNCB/Lipikar (reference products) groups. Once daily application of either Eczekalm or Atopiclair® or Lipikar on the AD lesion was performed from Day 32 to Day 38. The AD severity index (ADSI) and animal behaviour were monitored throughout the study. The trans-epidermal water loss (TEWL) was measured on the sacrifice day (Day 39). RESULTS: At Day39, ADSI in the DNCB/Eczekalm, DNCB/Lipikar, and DNCB/Atopiclair® groups were significantly lower by -70%, -68%, and -57%, respectively, as compared to DNCB/- (p < 0.001). No sign of erythema was observed in the DNCB/Eczekalm group. Mean scores of skin oedema, excoriation, and dryness in the DNCB/Eczekalm, DNCB/Lipikar, and DNCB/Atopiclair® groups were significantly lower than in the DNCB/-. No significant difference was observed between DNCB/Eczekalm and DNCB/Lipikar groups. Mean TEWL in DNCB/Eczekalm group was significantly lower than the ones of DNCB/Atopiclair® (-43%, p < 0.001) and DNCB/Lipikar (-15%, p < 0.05). CONCLUSION: Eczekalm treatment significantly reduced the inflammatory effects due to AD and itching episodes and restored the skin barrier function.

Clinical study on the efficacy, acceptance, and safety of hearing aids in patients with mild to moderate presbyacusis.

BACKGROUND: The primary objective of this trial was to demonstrate the effect of wearing a Hearing aid (HA) on improvement of hearing and comprehension in everyday life situations. METHODS: This single-center phase IV open-label clinical trial was carried out on men or women 40 years old or more, presenting mild or moderate first-degree presbyacusis. Presbyacusis was diagnosed by performance of pure-tone audiometry in silence. The main criterion was the comparison of the Glasgow Hearing Aid Benefit Profile (GHABP) before wearing HA and after a month of use and the secondary one was audiometric parameters. RESULTS: Forty-seven patients (mean age 60.0±6.9 years) were included in the study. After 4 weeks, when wearing HA, no significant difficulty remains in the patients when they watch television (GHABP situation 1) or when they have a conversation without background noise (GHABP situation 2). To have a conversation in a busy street or a shop GHABP (situation 3) 4.4% of patients still have great difficulty, as are 2.2% of them when participating in a group conversation (GHABP situation 4). The GHABP score of residual disability for the whole of the 4 situations of difficulty is 1.3±0.5, translating into no or only slight residual disability, in very significant amelioration of 1.3±0.7 points (P<0.0001), or 46.4% compared to the initial value. Audiometric parameters were also significantly improved. CONCLUSIONS: This study has allowed us to highlight from a clinical as well as an audiometric perspective the safety, effectiveness, as well as the important benefit of Sonalto® pre-set hearing aids on the improvement of hearing in patients presenting incipient presbyacusis.

Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study.

BACKGROUND: Patients with type IIb, or mixed, dyslipidemia have high levels of low-density lipoprotein cholesterol (LDL-C) with predominance of small dense LDL particles, high levels of triglycerides (TG), and low levels of high-density lipoprotein cholesterol (HDL-C). Fenofibrate significantly reduces TG and, more moderately, LDL-C, increases HDL-C and produces a shift from small to large LDL particle size; the main effect of ezetimibe is a reduction in LDL-C levels. Combined treatment with fenofibrate and ezetimibe may correct all the abnormalities of type IIb dyslipidemia. OBJECTIVE: To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal(R)) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome compared with administration of fenofibrate and ezetimibe alone (ClinicalTrials.gov Identifier: NCT00349284; Study ID: CLF178P 04 01). METHODS: This was a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Sixty ambulatory patients (mean age 56 years; 50% women, 50% men) were treated in each group. For inclusion in the study, patients were required to have LDL-C >or=4.13 mmol/L (>or=160 mg/dL), TG >or=1.71 mmol/L and or=150 mg/dL and

A single dose, three-arm, placebo-controlled, phase I study of the bradykinin B2 receptor antagonist Anatibant (LF16-0687Ms) in patients with severe traumatic brain injury.

Traumatic brain injury (TBI) mortality and morbidity remains a public health challenge. Because experimental studies support an important role of bradykinin (BK) in the neurological deterioration that follows TBI, a double-blind, randomized, placebo-controlled study of Anatibant (LF16- 0687Ms), a selective and potent antagonist of the BK B(2) receptor, was conducted in severe (Glasgow Coma Scale [GCS] < 8) TBI patients (n = 25) at six sites in the United States. At 8-12 h after injury (9.9 +/- 2.8 h), patients received a single subcutaneous injection of Anatibant (3.75 mg or 22.5 mg, n = 10 each) or placebo (n = 5). The primary objective was to investigate the pharmacokinetics of Anatibant; general safety, local tolerability, levels of the bradykinin metabolite BK1-5 in plasma and cerebrospinal fluid (CSF), intracranial pressure (ICP), and cerebral perfusion pressure were also assessed. We observed a dose-proportionality of the pharmacokinetics, Cmax, and AUC of Anatibant. V(d)/F, Cl/F, and t(1/2) were independent on the dose and protein binding was >97.7%. Anatibant, administered as single subcutaneous injections of 3.75 g and 22.5 mg, was well tolerated in severe TBI patients with no unexpected clinical adverse events or biological abnormalities observed. Interestingly, plasma and CSF levels of BK1-5 were significantly and markedly increased after trauma (e.g., 34,700 +/- 35,300 fmol/mL in plasma vs. 34.9 +/- 5.6 fmol/mL previously reported for normal volunteers), supporting the use of Anatibant as a treatment of secondary brain damage. To address this issue, a dose-response trial that would investigate the effects of Anatibant on the incidence of raised ICP and on functional outcome in severe TBI patients is needed.