Mauricio Odio

Continuous Topical Administration of a Petrolatum Formulation by a Novel Disposable Diaper

Background: Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence of this problem, we have developed a novel diaper to deliver to the skin dermatological formulations intended to help protect the skin from overhydration and irritation. Objective: To determine the clinical benefits of a novel disposable diaper designed to deliver a petrolatum-based formulation continuously to the skin during use. Methods: Two independent, blinded, randomized clinical trials were conducted, involving an aggregate total of 391 children, 8–24 months of age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The studies determined the effects of the novel diaper on skin erythema and diaper rash. Results: Use of the formulation-treated diaper was associated with significant reductions in severity of erythema and diaper rash compared to the control product. Conclusions: The results demonstrated the clinical benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. We anticipate that this advance in diaper design will contribute significantly to further reduce the prevalence and severity of irritant contact dermatitis in the diaper area.

Skin Care in the NICU Patient: Effects of Wipes versus Cloth and Water on Stratum Corneum Integrity

Background: NICU patients are at risk of skin breakdown due to prematurity, irritant exposure, medical status and stress. There is a need to minimize damage, facilitate skin development and reduce infection risk, but the literature on the effects of skin care practices in NICU patients is limited. Objectives: To test the hypothesis that baby diaper wipes with emollient cleansers and a soft cloth would minimize skin compromise relative to cloth and water. Methods: In 130 NICU infants (gestational age 23–41 weeks, at enrollment 30–51 weeks), measurements of skin condition, i.e., skin erythema, skin rash, transepidermal water loss (TEWL) and surface acidity (pH), within the diaper and at diaper and chest control sites were determined daily for 5–14 days using standardized methods. Treatments were randomly assigned based on gestational age and starting skin irritation score: wipe A, wipe B, and the current cloth and water NICU standard of care. Results: Perineal erythema and TEWL were significantly lower for wipes A and B than cloth and water beginning at day 5 for erythema (scores of 1.11 ± 0.05, 1.2 ± 0.05, and 1.4 ± 0.06, respectively) and day 7 for TEWL (28.2 ± 1.6, 28.8 ± 1.6, and 35.2 ± 1.6 g/m2/h, respectively). Wipe B produced a significantly lower skin pH (day 5, 5.47 ± 0.03) than wipe A (5.71 ± 0.03) and cloth and water (5.67 ± 0.04). The starting skin condition, stool total, age and time on current standard impacted the outcomes. Conclusions: Both wipes are appropriate for use on medically stable NICU patients, including both full and preterm infants, and provide more normalized skin condition and barrier function versus the cloth and water standard. Wipe B may facilitate acid mantle development and assist in colonization, infection control and barrier repair. Neonatal skin continues to change for up to 8 weeks postnatally, presumably as it adapts to the dry extra-uterine environment.

Newborn infant skin: physiology, development, and care.

Infant skin is critical to the newborn childs transition from the womb environment to the journey to self-sufficiency. This review provides an integrative perspective on the skin development in full term and premature infants. There is a particular focus on the role of vernix caseosa and on the implications of skin development for epidermal penetration of exogenous compounds. Healthy full-term newborn skin is well-developed and functional at birth, with a thick epidermis and well-formed stratum corneum (SC) layers. Transepidermal water loss is very low at birth, equal to, or lower than adults, indicating a highly effective skin barrier. Vernix facilitates SC development in full-term infants through a variety of mechanisms including physical protection from amniotic fluid and enzymes, antimicrobial effects, skin surface pH lowering, provision of lipids, and hydration. Premature infants, particularly those of very low birth weight, have a poor skin barrier with few cornified layers and deficient dermal proteins. They are at increased risk for skin damage, increased permeability to exogenous agents and infection. The SC barrier develops rapidly after birth but complete maturation requires weeks to months. The best methods for caring for infant skin, particularly in the diaper region, are described and related to these developmental changes.

Efficacy of different strategies to treat anemia in children: a randomized clinical trial.

BackgroundAnemia continues to be a major public health problem among children in many regions of the world, and it is still not clear which strategy to treat it is most effective.ObjectiveTo evaluate the efficacy and childrens acceptance of several recognized strategies to treat anemia.MethodsNon-breastfed children (n = 577), 6 to 43 mo of age, were screened for the trial; 267 were anemic (hemoglobin < 11.7 g/dL), and 266 of those were randomized into 1 of 5 treatments to received daily either: an iron supplement (IS), an iron+folic acid supplement (IFS), a multiple micronutrient supplement (MMS), a micronutrient-fortified complementary food as porridge powder (FCF), or zinc+iron+ascorbic acid fortified water (FW). The iron content of each daily dose was 20, 12.5, 10, 10 and 6.7 mg respectively. Hemoglobin (Hb), ferritin, total iron, weight and height were measured at baseline and after 4 months of treatment. Morbidity, treatment acceptability and adherence were recorded during the intervention.ResultsAll treatments significantly increased Hb and total iron concentration; ferritin did not change significantly. Groups MMS, IS and IFS increased Hb (g/dL) [1.50 (95%CI: 1.17, 1.83), 1.48 [(1.18, 1.78) and 1.57 (1.26, 1.88), respectively] and total iron ((μg/dL) [0.15 (0.01, 0.29), 0.19 (0.06, 0.31) and 0.12(-0.01, 0.25), respectively] significantly more than FCF [0.92 (0.64, 1.20)] but not to FW group [0.14 (0.04, 0.24)]. The prevalence of anemia was reduced to a greater extent in the MMS and IFS groups (72% and 69%, respectively) than in the FCF group (45%) (p < 0.05). There were no significant differences in anthropometry or in the number of episodes of diarrhea and respiratory infections among treatment groups. The supplements MMS and IS were less acceptable to children, than IFS, FCF and FW.ConclusionThe three supplements IS, ISF and MMS increased Hb more than the FCF; the supplements that contained micronutrients (IFS and MMS) were more effective for reducing the prevalence of anemia. In general, fortified foods were better accepted by the study participants than supplements.ClinicalTrial.gov IdentifierNCT00822380

Maternal reproductive effects of oral salicylic acid in Sprague-Dawley rats

Clinical and experimental evidence indicates that exposure to relative ly large doses of acetylsalicylic acid (ASA) prolongs parturition. However, little is known about the dose-response relationship for salicylate-related effects on labor and gestation. As well, the relative potency of salicylic acid (SA) as compared with ASA for these reproductive effects has not been well investigated. This study was designed to define a dose-response relationship for salicylic acid (SA) effects on labor and gestation times in Sprague-Dawley rats. Pregnant females received oral doses of 20,80, or 200 mg/kg/day sodium salicylate, or 260 mg/kg/day acetylsalicylic acid (ASA), as a positive control, on days 15 through 21 of gestation (sperm positive = day 0). Onset of labor was followed in each animal beginning on day 21 of gestation. The data failed to demonstrate a substantial potency difference between ASA and SA but some differences in toxicity were observed. Relative to controls, gestation times were unaffected by SA. SA treatment resulted in a dose-related trend towards increased duration of labor which was statistically significant at 200 mg/kg/day of SA. ASA treatment of pregnant females resulted in both prolonged labor and gestation times. Both the highest administered dose of SA and ASA treatment contributed to increased maternal peripartum death. Overall, the study confirms a dose-response relationship for SA-induced maternal reproductive effects and supports a no observable effect level (NOEL) for this compound of 80 mg/kg/day for adverse effects on parturition.

Diapering, Diaper Technology, and Diaper Area Skin Health

Disposable diapers are the most common diaper care practice in Western societies today, and their use continues to increase globally. Improvements in disposable diaper technology have helped to reduce the prevalence and severity of diaper dermatitis (DD) over the course of the last few decades. This article reviews how changes in disposable diaper technology interact with the various etiological factors in DD, thus helping to improve overall diaper area skin health for children around the world.

Evaluation of subchronic (13 week), reproductive, and in vitro genetic toxicity potential of 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate (octocrylene)

Use of 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate (Octocrylene) in commercial sunscreen products has increased considerably in recent years. To support larger scale human exposure to this compound, additional toxicological information was needed in several key areas. The present studies evaluated subchronic toxicity, developmental toxicity, and in vitro genotoxic potential of Octocrylene. In the subchronic study, male and female New Zealand white (NZW) rabbits treated topically with concentrations of octocrylene up to 534 mg/kg/day for 13 weeks showed slight to moderate dose-dependent skin irritation that correlated positively with a mild depression in body weight gain. Lack of associated histopathologic or clinical hematology abnormalities suggested that the body weight effect probably reflected a nonspecific response to topical irritation. In percutaneous developmental toxicity studies, NZW does were treated topically with Octocrylene at levels up to 267 mg/kg/day on Days 6 through 18 of gestation. Body weight gain, food consumption, and all maternal, reproductive, and offspring parameters evaluated were comparable between Octocrylene-treated and control animals. In the oral developmental toxicity assay, female CD-1 mice received oral doses of Octocrylene up to 1000 mg/kg/day on Days 8-12 of gestation. No evidence of maternal or developmental toxicity was seen at any dose tested. Genotoxicity was evaluated in vitro using the Chinese hamster ovary cell assay to assess clastogenicity and the mouse lymphoma cell assay to assess forward gene mutations. Octocrylene did not induce any significant increase in genotoxicity. This evaluation of toxicological potential supports the use of Octocrylene as a human photoprotectant.

Modern diaper performance: construction, materials, and safety review

A review of the literature on diapers and diaper rash reveals that many clinicians are unfamiliar with modern diaper construction and materials as well as diaper safety testing methods. Typical modern diapers do not contain ingredients of concern such as latex and disperse dyes, but use ingredients such as spandex and pigments with a favorable safety profile. Todays disposable diaper is a high performance product whose carefully designed layers and liners provide optimal urine and feces absorption and an ever more clothing‐like and comfortable fit. This is possible due to a variety of specialized polymer materials that provide optimal absorption of urine and feces, thereby minimizing skin exposure.

Setting the Record Straight on Diaper Rash and Disposable Diapers

Skin in the diapered area is continuously threatened by exposure to changes in pH levels, overhydration, mechanical friction, and fecal enzymes, making diaper rash a common occurrence among babies. Up to one third of infants may exhibit clinical symptoms of diaper rash at any time, and more than half of babies between the ages of 4 and 15 months develop diaper rash at least once in a 2-month period. Despite misperceptions that disposable diapers are related to an increase in diaper rash, the incidence of diaper dermatitis is on the decline, largely due to significant improvements in disposable diaper construction and materials. Modern-day disposable diapers are specifically designed to limit exposure to irritants in the diaper area, reduce overhydration, inhibit skin barrier compromise, and help maintain normal skin pH levels and have been thoroughly evaluated for safety and skin compatibility.

Quantitative characterization of mechanically indented in vivo human skin in adults and infants using optical coherence tomography

Abstract. Influenced by both the intrinsic viscoelasticity of the tissue constituents and the time-evolved redistribution of fluid within the tissue, the biomechanical response of skin can reflect not only localized pathology but also systemic physiology of an individual. While clinical diagnosis of skin pathologies typically relies on visual inspection and manual palpation, a more objective and quantitative approach for tissue characterization is highly desirable. Optical coherence tomography (OCT) is an interferometry-based imaging modality that enables in vivo assessment of cross-sectional tissue morphology with micron-scale resolution, which surpasses those of most standard clinical imaging tools, such as ultrasound imaging and magnetic resonance imaging. This pilot study investigates the feasibility of characterizing the biomechanical response of in vivo human skin using OCT. OCT-based quantitative metrics were developed and demonstrated on the human subject data, where a significant difference between deformed and nondeformed skin was revealed. Additionally, the quantified postindentation recovery results revealed differences between aged (adult) and young (infant) skin. These suggest that OCT has the potential to quantitatively assess the mechanically perturbed skin as well as distinguish different physiological conditions of the skin, such as changes with age or disease.