Hard water softening effect of a baby cleanser.

BACKGROUND: Hard water is associated with atopic dermatitis (eczema). We wanted to determine if a baby cleanser and its individual components altered free ionized calcium (Ca2+) in a simulated hard water baby bath. For these studies, an in vitro determination of free Ca2+ in a simulated hard water baby bath, and an in vivo exploratory study of free Ca2+ absorption into skin from hard water were performed. METHODS: Free Ca2+ was measured with an ion-sensitive electrode in vitro in hard water (100-500 ppm, Ca2+) before and after addition of the cleanser and/or its components. In an exploratory study, absorption of Ca2+ into skin from hard water was determined in three female participants (aged 21-29 years). RESULTS: At an in-use dilution of 1%, the test cleanser reduced free Ca2+ from ~500 ppm to <200 ppm; a 10% in-use dilution bound virtually all free Ca2+. The anionic surfactant component contributed the most to this effect. In the exploratory in vivo study, we measured a reduction of ~15% in free Ca2+ from simulated hard water over 10 minutes. CONCLUSION: Baby cleansers can bind free Ca2+ and reduce the effective water hardness of bath water. Reducing the amount of free Ca2+ in the water will reduce the availability of the ion for binding to the skin. Altering or reducing free Ca2+ concentrations in bath water may be an important parameter in creating the ideal baby bath.

Human Cumulative Irritation Tests of Common Preservatives Used in Personal Care Products: A Retrospective Analysis of Over 45 000 Subjects.

The cumulative irritation test (CIT) is an accepted method used to evaluate the skin irritation potential and safety of individual ingredients and formulas of leave-on skin care and cosmetic compounds. Here, we report the results of CITs collected by JOHNSON & JOHNSON Consumer Companies, Inc. (Skillman, NJ), part of an extensive tiered program to evaluate product safety. In the CIT, test formulations were applied to the skin of adults (18-70 years) with no known skin disease or allergies, 3 times per week for 2 weeks using semi-occlusive clinical patches. Preservatives were 1 of up to 16 components of test formulas, and included ethylenediaminetetraacetic acid, diazolidinyl urea, 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione, parabens, isothiazolinone, phenoxyethanol, sorbates, or benzoates. Skin sites were scored after each patch removal using a 5-point scale, with 0 = no visible reaction and 4 = erythema, marked edema, or substantial vesiculation. Scores were reported as percentage of maximal irritation score. Data were analyzed from 1363 CIT studies (over 45 000 subjects). There were no significant differences in percentage of maximal scores between formulas grouped by preservative types (p > .1). Median score across the entire dataset was 0.44, with most formulas showing none or mild irritation. Although seasonal variations were observed, no correlation was noted between score and preservative concentration. In conclusion, in a large, normal subject dataset, preservatives at typical in-use concentrations did not appear to contribute to skin irritation.

40 years of topical tretinoin use in review.

Topical tretinoin has been approved for use in dermatology for 40 years and is currently approved for the treatment of acne vulgaris and photodamage. During this time, topical tretinoin has accumulated significant efficacy and safety data in the treatment of acne and photodamaged skin and demonstrated clinical potential for treating a range of other dermatologic conditions. The diverse effects may be due to complex underlying mechanisms of action associated with tretinoin, including keratolytic activity, collagenesis, and other mechanisms associated with the activation of nuclear retinoic acid receptors (RARα, RARß, and RARγ). In this article, we review the history of topical tretinoin use to date and outline emerging research suggesting that topical tretinoin may have potential clinical use for treating a multitude of other dermatological conditions when used either as monotherapy or in combination with other agents. We also describe newer formulations of topical tretinoin that have been designed to reduce irritation potential. In light of the substantial history of safety and efficacy of topical tretinoin in acne and photodamage, we speculate that it holds promise in treating many additional dermatological conditions, which may be explored in future research.

Use of topical tretinoin and the development of noncutaneous adverse events: evidence from a systematic review of the literature.

BACKGROUND: Topical retinoids have been in clinical use for the treatment of chronic skin conditions, including acne, photodamage, and psoriasis, for 30 years. OBJECTIVE: A systematic literature review was conducted to assess the incidence of noncutaneous adverse events (AE) among patients treated with topical retinoids with a focus on topical tretinoin studies reported before the Veterans Affairs Topical Tretinoin Chemoprevention trial. METHODS: Electronic literature searches were conducted in Embase and MEDLINE for literature reporting development of nonteratogenic, noncutaneous AE among patients treated with topical retinoids published through September 2008. RESULTS: The search yielded 2778 citations, of which 20 studies met inclusion criteria. Tretinoin was used in 14 of the studies. Other retinoids assessed included isotretinoin, adapalene, alitretinoin, and tazarotene. Within patients receiving topical tretinoin, 27.9% reported the occurrence of at least one noncutaneous AE. The majority of noncutaneous AE were transient and judged not to be related to tretinoin treatment. LIMITATIONS: The conclusions of this study apply largely to tretinoin compared with other topical retinoids. Many of the included trials were designed to evaluate the efficacy of topical treatment and reporting of safety events concentrated on incidence of localized AE, rather than systemic or noncutaneous events. CONCLUSION: We found no clear evidence of a relationship between the use of topical tretinoin and the development of noncutaneous AE before a recent report of excess mortality in a clinical trial. The majority of noncutaneous AE reported by patients receiving topical retinoids consisted of nonsevere, nonspecific symptoms that were judged not to be related to treatment.

Nitrogen and phosphorus transport in runoff from compost berms on a simulated military training landscape.

Compost mulches have potential to significantly offset on- and off-site environmental impacts resulting from mechanical soil disturbances and training manoeuvres on military training ranges. N and P transport was investigated in runoff from compost mulch berms made from various organic waste materials in combination with each other and with soil on a simulated military training landscape in north Alabama in 2007 and 2008. Berms were constructed using composted municipal yard waste (YW), wood chips (WC), pine bark fines (PB), and soil (SL) mixed in eight different proportions. Berms made from 100% soil which had a cumulative runoff PO(4)-P content of 12 mg L(-1) posed the greatest threat of negatively impacting the environment from inorganic P transport. Using compost mulch material with 40% soil to build berms reduced the potential for yard waste and wood chips to cause off-site negative environmental impacts from total dissolved solids, N, and P transport. Berms made from 100% pine bark fines which had cumulative runoff values of 760, 9, 22 and 5 mg L( -1), respectively, of TDS, NH(4)-N, NO(3)-N, and PO( 4)-P had the least potential to cause negative off-site environmental impact. To prevent negative impacts of nutrient transport in runoff from berms on training landscapes, the sites need to be well buffered to hydrologically isolate them from adjoining ecosystems.

A post hoc subgroup analysis of an 18-day randomized controlled trial comparing the tolerability and efficacy of mixed amphetamine salts extended release and atomoxetine in school-age girls with attention-deficit/hyperactivity disorder.

BACKGROUND: Because the scientific literature on the pharmacotherapy of attention-deficit/hyperactivity disorder (ADHD) is almost entirely based on the results of studies in samples consisting primarily of boys, much is unknown about the treatment response in girls. OBJECTIVE: This post hoc analysis compared the efficacy, tolerability, and time course of the effect of mixed amphetamine salts extended release (MAS XR) and atomoxetine in school-age girls with ADHD. METHODS: This was an intent-to-treat subanalysis of the data from girls enrolled in a multicenter, 18-day, randomized, double-blind, parallel-group, forced dose-titration, laboratory school study enrolling boys and girls aged 6 to 12 years with ADHD. The study compared the efficacy, tolerability, and time course of the effect of increasing doses of MAS XR (10, 20, and 30 mg/d) and atomoxetine (0.5 and 1.2 mg/kg per day). The laboratory school sessions were organized in cycles to include 12 hours of observation. Efficacy measures included the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) deportment rating subscale, the SKAMP attention rating subscale, and academic testing (number of math problems attempted and answered correctly). Adverse events were assessed throughout the study period. Tolerability and efficacy measures were assessed during laboratory school visits on days 7, 14, and 21. RESULTS: This subanalysis included 57 girls (median age, 9 years; 49.1% white, 22.8% black, 17.5% Hispanic) with a diagnosis of ADHD, combined subtype. Twenty-six girls were randomized to receive MAS XR and 31 were randomized to receive atomoxetine. Mean SKAMP deportment and attention subscale scores in the 2 groups were similar at baseline. Mean changes from baseline were significantly greater for MAS XR compared with atomoxetine on the SKAMP deportment score (-0.48 vs -0.04, respectively; P<0.001) and SKAMP attention score (-0.45 vs -0.05; P<0.001). The time course of medication effect, based on change from baseline in SKAMP deportment scores, indicated 12-hour efficacy for MAS XR at hours 2, 4.5, 7, 9.5, and 12 (all time points, P<0.01 vs baseline) but not for atomoxetine. At the end of the study, both treatment groups had a significant increase from baseline in the mean number of math problems attempted and answered correctly (P<0.001). Girls who received MAS XR attempted significantly greater numbers of problems compared with those who received atomoxetine (P=0.04). Both MAS XR and atomoxetine were well tolerated. The most frequently occurring treatment-related adverse events in girls receiving MAS XR were decreased appetite (40.7%), upper abdominal pain (29.6%), insomnia (25.9%), and headache (14.8%). The most frequently occurring treatment-related adverse events in girls receiving atomoxetine were somnolence (28.1%), upper abdominal pain (15.6%), vomiting (15.6%), nausea (12.5%), and decreased appetite (12.5%). CONCLUSION: This post hoc analysis in a subpopulation of girls with ADHD, combined subtype, found that 18-day treatment with MAS XR was significantly more effective than atomoxetine in terms of ratings of classroom behavior, attention, and academic productivity.

A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder.

Mixed amphetamine salts extended release (MAS XR; Adderall XR) and atomoxetine (Strattera) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder (ADHD) combined or hyperactive/impulsive type in a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study. Primary efficacy measure was the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) behavioral rating scale. Changes in mean SKAMP deportment scores from baseline were significantly greater for MAS XR (n = 102) than for atomoxetine (n = 101) overall (-0.56 and -0.13, respectively; p < .0001) and at each week (p < .001). Adverse events were similar for both treatment groups. The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than atomoxetine in children with ADHD.