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Study B (study + b)
Selected AbstractsSkin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaperJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 2001S Baldwin Abstract Background Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence of this problem, we have advanced in our development of a novel diaper that delivers dermatological formulations to help protect the skin from over-hydration and irritation. Objective To determine the clinical benefits of a novel disposable diaper designed to deliver a zinc oxide and petrolatum-based formulation continuously to the skin during use. Methods All studies were independent, blinded, randomized clinical trials. Study A was conducted to confirm transfer of the zinc oxide/petrolatum (ZnO/Pet) formulation from the diaper to the child's skin during use. Children wore a single diaper for 3 h or multiple diapers for 24 h. After the use period, stratum corneum samples were taken from each child and analysed for ZnO/Pet. Study B evaluated the prevention of skin irritation and barrier damage from a standard skin irritant (SLS) in an adult arm model. Study C evaluated skin erythema and diaper rash in 268 infants over a 4-week usage period. One half of the infants used the ZnO/Pet diaper, while the other half used a control diaper that was identical except for the absence of the ZnO/Pet formulation. Results The ointment formulation and ZnO transferred effectively from the diaper to the child's skin during product use. Transfer of ZnO increased from 4.2 µg/cm2 at 3 h to > 8 µg/cm2 at 24 h. Exposure to the formulations directly on adult skin prior to an irritant challenge was associated with up to a 3.5 reduction in skin barrier damage and skin erythema. Greatest reductions were seen for the ZnO containing formulations. Wearing of the formulation treated diaper was also associated with a significant reduction in skin erythema and diaper rash compared to the control product. Conclusions The results demonstrated the clinical benefits associated with continuous topical administration of a zinc oxide/petrolatum-based formulation by this novel diaper. [source] Efficacy and safety of dirlotapide in the management of obese dogs evaluated in two placebo-controlled, masked clinical studies in North AmericaJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 2007J. A. WREN Dirlotapide was evaluated in the management of obesity in dogs in two multicenter, clinical studies in North America. A total of 335 obese dogs of various breeds were randomized to dirlotapide or placebo in a 2:1 ratio. Dirlotapide was administered orally once daily to dogs at an initial dose of 0.05 mg/kg, increased after 14 days to 0.1 (study B, label dose) or 0.2 mg/kg (study A) and then adjusted according to individual weight loss at 28-day intervals. Dogs were examined and weighed, and body condition scores (BCSs) were recorded every 28 days. Study A had three consecutive phases: weight loss (16 weeks, day 0,112); weight management (12 weeks); and post-treatment (8 weeks). Study B had a weight loss phase only. For dirlotapide-treated dogs, mean weight loss by day 112 was 11.8,14.0% compared with 3.0,3.9% for placebo (P = 0.0001). In study A, weight losses for dirlotapide were 19.3% after 12 weeks of weight management and 16.7% (regain of 3.4%) by 8 weeks after dirlotapide was discontinued. In both studies, dogs in both treatments had emesis, lethargy, anorexia, diarrhea, and mildly elevated hepatic transaminase activity, that resolved spontaneously with time. These were experienced more frequently with dirlotapide. Improved activity levels and BCS for >50% dogs were reported with dirlotapide. Dirlotapide was safe and effective in the reduction and management of body weight in obese dogs. [source] Seasonal and circadian variation in salivary testosterone in rural Bolivian menAMERICAN JOURNAL OF HUMAN BIOLOGY, Issue 6 2009Virginia J. Vitzthum Testosterone (T) plays a key role in the increase and maintenance of muscle mass and bone density in adult men. Life history theory predicts that environmental stress may prompt a reallocation of such investments to those functions critical to survival. We tested this hypothesis in two studies of rural Bolivian adult men by comparing free T levels and circadian rhythms during late winter, which is especially severe, to those in less arduous seasons. For each pair of salivary TAM/TPM samples (collected in a , 12-h period), circadian rhythm was considered classic (CCLASSIC) if TAM > 110%TPM, reverse (CREVERSE) if TPM > 110%TAM, and flat (CFLAT) otherwise. We tested the hypotheses that mean TAM > mean TPM and that mean TLW < mean TOTHER (LW = late winter, OTHER = other seasons). In Study A, of 115 TPM,TAM pairs, 51% = CCLASSIC, 39% = CREVERSE, 10% = CFLAT; in Study B, of 184 TAM,TPM pairs, 55% = CCLASSIC, 33% = CREVERSE, 12% = CFLAT. Based on fitting linear mixed models, in both studies TOTHER-AM > TOTHER-PM (A: P = 0.035, B: P = 0.0005) and TOTHER-AM > TLW-AM (A: P = 0.054, B: P = 0.007); TPM did not vary seasonally, and T diurnality was not significant during late winter. T diurnality varied substantially between days within an individual, between individuals and between seasons, but neither T levels nor diurnality varied with age. These patterns may reflect the seasonally varying but unscheduled, life-long, strenuous physical labor that typifies many non-industrialized economies. These results also suggest that single morning samples may substantially underestimate peak circulating T for an individual and, most importantly, that exogenous signals may moderate diurnality and the trajectory of age-related change in the male gonadal axis. Am. J. Hum. Biol., 2009. © 2009 Wiley-Liss, Inc. [source] Almotriptan Increases Pain-Free Status in Patients With Acute Migraine Treated in Placebo-Controlled Clinical TrialsHEADACHE, Issue 2002FRCP(C), Ninan T. Mathew MD Objectives.,Evaluate the efficacy of a single oral dose of almotriptan in achieving pain-free status during treatment of acute migraine attacks. Methods.,This pooled analysis (N=1321) used data from two randomized, placebo-controlled, phase III trials (studies A and B) to determine the proportion of patients with migraine achieving pain-free status 2 hours after a single oral dose of study medication (almotriptan or placebo). Pain was assessed using a 4-point integer scale (0=no headache, 3=severe headache), and recorded in a patient self-assessment booklet. Results.,The proportion of patients pain-free at 2 hours after study medication was significantly greater with almotriptan 6.25 mg (both studies P,.002) and almotriptan 12.5 mg (both studies P,.001) than with placebo. In study A, 11.6% of patients taking almotriptan 12.5 mg versus 2.5% of patients receiving placebo were pain-free at 1 hour (P=.016). At 1.5 hours, 26.8% of patients taking almotriptan 12.5 mg versus 8.8% receiving placebo (P=.001) were pain-free, and at 2 hours, 38.4% on almotriptan versus 11.3% on placebo were pain-free (P<.001). In study B, 23.8% of patients taking almotriptan 12.5 mg were free from pain at 1.5 hours versus 10.2% receiving placebo (P<.001). At 2 hours, 39.2% taking almotriptan 12.5 mg versus 15.3% receiving placebo were pain-free (P<.001). Increases in pain-free status with almotriptan generally occurred in a dose-dependent manner. Conclusion.,Compared with placebo, almotriptan 12.5 mg significantly increases the proportion of patients who are pain-free by as early as 1 hour, and consistently by 1.5 hours, after a single dose. [source] Efficacy and safety of dirlotapide in the management of obese dogs evaluated in two placebo-controlled, masked clinical studies in North AmericaJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 2007J. A. WREN Dirlotapide was evaluated in the management of obesity in dogs in two multicenter, clinical studies in North America. A total of 335 obese dogs of various breeds were randomized to dirlotapide or placebo in a 2:1 ratio. Dirlotapide was administered orally once daily to dogs at an initial dose of 0.05 mg/kg, increased after 14 days to 0.1 (study B, label dose) or 0.2 mg/kg (study A) and then adjusted according to individual weight loss at 28-day intervals. Dogs were examined and weighed, and body condition scores (BCSs) were recorded every 28 days. Study A had three consecutive phases: weight loss (16 weeks, day 0,112); weight management (12 weeks); and post-treatment (8 weeks). Study B had a weight loss phase only. For dirlotapide-treated dogs, mean weight loss by day 112 was 11.8,14.0% compared with 3.0,3.9% for placebo (P = 0.0001). In study A, weight losses for dirlotapide were 19.3% after 12 weeks of weight management and 16.7% (regain of 3.4%) by 8 weeks after dirlotapide was discontinued. In both studies, dogs in both treatments had emesis, lethargy, anorexia, diarrhea, and mildly elevated hepatic transaminase activity, that resolved spontaneously with time. These were experienced more frequently with dirlotapide. Improved activity levels and BCS for >50% dogs were reported with dirlotapide. Dirlotapide was safe and effective in the reduction and management of body weight in obese dogs. [source] Taxonomic sufficiency in two case studies: where does it work better?MARINE ECOLOGY, Issue 2009Tiziano Bacci Abstract In marine macrobenthos studies the identification of organisms at species level is the best entry to ecological and biological information about the animals. An accurate identification requires excellent conservation of the organisms, reliable fauna description, experts and lengthy work in the laboratory. The aim of this work is to test taxonomic sufficiency (TS) in two deliberately selected different case studies to understand whether and how the taxonomic complexity of a benthic assemblage influences the results of TS and where it works better. The first benthic settlement was collected in an area characterized by homogeneous depth and grain size composition (case study A) around an off-shore gas platform, while the second one was collected along a coast-wide transect in an area with human pressure limited to fishing activities (case study B). Univariate and multivariate statistical analysis was used to assess differences in the taxonomic structure of benthic assemblages and to test TS on the two different datasets. TS seems to work in both sites, from species to higher taxonomic levels, and the family taxonomic level appears the best compromise for taxonomic resolution when an accurate identification is not achievable. The application of TS does not indicate a significant difference between the two datasets and appears therefore to be a valid instrument to analyse and describe the structure of benthic settlements in the case of taxonomically complex communities. [source] | |||||||||||||