Effect of Diaper Cream and Wet Wipes on Skin Barrier Properties in Infants: A Prospective Randomized Controlled Trial

The effect of different diaper care procedures on skin barrier function in infants has been minimally investigated and may be assessed using objective methods. In a single‐center, prospective trial, 89 healthy 9‐month‐old infants (±8 wks) were randomly assigned to three diaper care regimens: group I used water‐moistened washcloths at diaper changes (n = 30), group II additionally applied diaper cream twice daily (n = 28), and group III used wet wipes and diaper cream twice daily (n = 31). Transepidermal water loss (TEWL), skin hydration (SCH), skin pH, interleukin 1α (IL‐1α) levels, and microbiologic colonization were measured in diapered skin (upper outer quadrant of the buttocks), nondiapered skin (upper leg), and if diaper dermatitis (DD) occurred, using the most affected skin area at day 1 and weeks 4 and 8. Skin condition was assessed utilizing a neonatal skin condition score and diaper rash grade. On diapered skin, SCH decreased in groups II and III, whereas TEWL values were reduced in group II only. Skin pH increased in groups II and III. In general, SCH, skin pH, and IL‐1α levels were higher in healthy diapered skin than in nondiapered skin. The incidence and course of DD was comparable in all groups. Areas with DD had greater TEWL and skin pH than unaffected skin areas. Infants who received diaper cream had lower SCH and TEWL and higher pH levels in the diapered area than on nondiapered skin. No correlation with the occurrence of DD was found.     

Effects of moisturizing skincare on skin barrier function and the prevention of skin problems in 3‐month‐old infants: A randomized controlled trial

An effective newborn skincare protocol has not been established. We aimed to evaluate the effects of moisturizing skincare, including using lotion and reducing routine bathing. Our hypothesis was that moisturizing skincare would improve skin barrier function. This randomized controlled trial included 227 healthy Asian newborns between 1 week and 3 months old. We compared moisturizing skincare (bathing every 2 days and using lotion daily; intervention, n = 113) to daily bathing without lotion (control, n = 114). We assessed the skin barrier function (transepidermal water loss [TEWL], stratum corneum hydration [SCH], skin pH and sebum secretion) as a primary outcome at 3 months old. We also assessed the incidence of skin problems according to parents’ diary reports. Compared with the control, the intervention group had a lower face TEWL (mean ± standard deviation, 14.69 ± 7.38 vs 17.08 ± 8.26 g/m² per h, P = 0.033), higher face SCH (60.38 ± 13.66 vs 53.52 ± 14.55, P = 0.001) and higher body SCH (58.89 ± 12.96 vs 53.02 ± 10.08, P < 0.001). Compared with the control, newborns in the intervention group had significantly lower rates of diaper dermatitis between birth and 1 month old (6.3% vs 15.9%, P = 0.022), and tended to have lower rates of body skin problems between 1 and 3 months (42.1% vs 55.2%, P = 0.064). Moisturizing skincare was effective for improving skin barrier function and preventing newborns’ diaper dermatitis. The results of our study may help parents make informed decisions about newborn skincare.     

Diagnosis and management of diaper dermatitis in infants with emphasis on skin microbiota in the diaper area

Diaper dermatitis is the most common inflammatory skin eruption within the diaper area in infants and toddlers. Although it rarely causes problems for prolonged periods of time, it causes considerable distress for both infants and parents. Diapered skin is exposed to friction, excessive hydration, varying pH, and is in constant contact with urine and feces, both of which are highly irritant to the skin. The three most common types of diaper dermatitis include chaffing dermatitis, irritant contact dermatitis, and diaper candidiasis. However, a variety of other skin conditions may manifest in the diaper area. Candida albicans and Staphylococcus aureus are most frequently isolated from the affected area and are thought to have a predominant role in diaper dermatitis. The review includes an overview of the epidemiology, etiology, and common skin microbiota in the diaper area. State‐of‐the‐art strategies for diagnosis, management, and prevention of diaper dermatitis are also included. Appropriate skin care can help in the prevention of diaper dermatitis and can aid the reparation of the skin. This review discusses common causes, skin microbiota within the diapered area, differential diagnosis, and finally possible prevention and treatment recommendations. Recent findings have proven that the key to efficient eradication of irritant diaper dermatitis lies in its prevention.     

Documentation of impaired epidermal barrier in mild and moderate diaper dermatitis in vivo using noninvasive methods

The presence of irritants from feces and urine with the concurrent mechanical friction and occlusion creates an environment in the diapered area that renders the skin prone to diaper dermatitis. Besides being a source of discomfort to the infant, these skin irritations pose a risk of secondary infections. In this study, we used noninvasive in vivo techniques to define measurable parameters that correlate with diaper dermatitis pathophysiology. In 35 infants (16 with mild or moderate and 19 without diaper dermatitis) we compared skin of diapered areas afflicted with diaper dermatitis to lesion-free diapered sites and to skin outside the diapered area (thigh). Our findings show significantly elevated cutaneous erythema, pH, and hydration, with significantly compromised water barrier function in involved areas compared to nonlesional sites both within and outside the diapered area. Furthermore, skin pH in nonlesional diapered skin for the diaper dermatitis cohort was significantly higher compared to the nondiapered sites. These observations are consistent with the current understanding of pathological skin changes in diaper dermatitis. In this study, we demonstrate that noninvasive methods can document relevant parameters to diaper dermatitis in vivo.     

Prevention of Diaper Dermatitis in Infants—a Literature Review

Diaper dermatitis (DD) is one of the most common skin conditions in neonates and infants, with a peak between the ages of 9 and 12 months. Appropriate skin care practices that support skin barrier function and protect the buttocks skin from urine and feces are supposed to be effective in the prevention of DD. Despite many recommendations for parents and caregivers on proper diaper skin care, there is no up‐to‐date synthesis of the available evidence to develop recommendations for DD prevention practice. Therefore we performed a systematic literature review on the efficacy of nonmedical skin care practices on the diapered area of healthy, full‐term infants ages 0 to 24 months. We identified 13 studies covering skin care practices such as cleansing, bathing, and application of topical products. DD prevalence and incidence and physiologic skin parameters were used as efficacy parameters. The results of this review indicate that cleansing of the diaper area using baby wipes or water and a washcloth have comparable effects on diapered skin. Bathing with a liquid baby cleanser twice weekly seems comparable with water alone. The application of ointments containing zinc oxide or petrolatum with or without vitamin A seems to have comparable effects on DD severity. There seems to be no information on whether single skin care practices such as cleansing, bathing, and application of topical preparations can prevent DD. High‐quality randomized clinical trials are needed to show the effectiveness of skin care practices for controlling and preventing DD.     

Association of Skin Wetness and pH With Diaper Dermatitis

Abstract: The strength of the association between diaper dermatitis and measurements of skin wetness and skin pH was evaluated by statistical analysis of four diaper trials involving 1601 infants. Although the strength of the association between skin wetness and diaper dermatitis was greater than that between skin pH and diaper dermatitis, increases in wetness and pH were both significantly associated with elevated mean grades for diaper dermatitis. The skin environment least likely to be associated with diaper dermatitis is one In which Increases In both skin wetness and skin pH are minimized.     

Development of diaper rash in the newborn

Diaper rash is a common infant malady. This study documents the earliest stages of rash in a cohort of 31 healthy term newborns over the first 28 days of life. The diaper area was evaluated using a standardized diaper rash grading scale. The anal, buttock, genital, intertriginous, waistband, and leg areas were assessed separately. At birth the average grade was 0.1 and none of the infants had specific features of advanced rash. Nineteen percent had dryness and/or slight redness. By day 7, 71% of infants had some features of skin compromise, giving rise to an overall grade of 0.6. Both the frequency and overall grade increased during postnatal weeks 2 and 3. Overall scores for days 21 and 28 were the same (1.1). The perianal area had the highest overall regional rash grade. Gender differences were present for the genital area only. These findings indicate that epidermal barrier breakdown is an uncommon finding at birth. Clinical signs of irritated skin in the diaper area develop progressively over the first postnatal month. A better understanding of the mechanisms conferring epidermal barrier protection at birth may be important for developing skin care products and practices to extend this protection later into life.     

Comparison of the Effect of Human Milk and Topical Hydrocortisone 1% on Diaper Dermatitis

Diaper dermatitis is one of the most common skin problems in infants and children, affecting between 7% and 35% of infants. This randomized clinical trial compared the efficacy of hydrocortisone 1% ointment with that of human breast milk in treating acute diaper dermatitis in infants ages 0 to 24 months. Infants with diaper rash were treated with either hydrocortisone 1% ointment (n = 70) or human breast milk (n = 71) for 7 days. Improvement in the rash from baseline was seen in both treatment groups on days 3 and 7; there was no significant difference in total rash scores on days 3 and 7. Treatment with human breast milk was as effective as hydrocortisone 1% ointment alone. Human breast milk is an effective and safe treatment for diaper dermatitis in infants.     

Changes in diapered and nondiapered infant skin over the first month of life

Time- and site-dependent differences in epidermal barrier properties were investigated over the first 28 days of life in healthy term newborn infants. Diapered and nondiapered skin sites were contrasted to the volar forearm of adults (mothers). Thirty-one term infants were evaluated in the hospital on postnatal day 1 and at home on days 4, 7, 14, 21, and 28 for a total of six visits. Measurements included baseline skin hydration, continuous capacitive reactance, peak water sorption, rate of water desorption, skin pH, skin temperature, and environmental conditions. Changes in epidermal barrier properties over the first 4 weeks of life included an increase in surface hydration, a decrease in transepidermal water movement under occlusion, a decrease in surface water desorption rate, and a decrease in surface pH. Diapered and nondiapered regions were indistinguishable at birth but exhibited differential behavior over the first 14 days, with the diapered region showing a higher pH and increased hydration. Maternal measurements remained constant throughout the period. We conclude that healthy newborn skin undergoes progressive changes in epidermal barrier properties over the first 28 days. Adult skin testing does not replicate newborn skin during the first month of life.     

Diaper Dermatitis: Etiology,Manifestations, Prevention,and Management

Pediatricians and parents report diaper dermatitis (DD) to be one of the most common skin diseases that affects almost every child at some point during the early months and years of life. Diapered skin is exposed to friction and excessive hydration, has a higher pH than nondiapered skin, and is repeatedly soiled with feces that contains enzymes with high irritation potential for the skin. The combination of these factors frequently results in skin damage, leading to visible erythematous lesions that can be irritating and painful to the child. Behavioral changes such as increased crying and agitation and changes in eating and sleeping patterns indicate emotional distress. Appropriate skin care can help to prevent the occurrence of DD and to speed up the healing of affected skin. This includes frequent diaper changes and aeration, gentle cleansing, and the use of a barrier cream. Mild to moderate cases usually resolve after a few days of following this routine, but the use of harsh cleaning products can exacerbate DD.     

Diaper dermatitis that does not quit

Diaper dermatitis is one of the most common skin disorders in infants. The humid, moist environment under the diaper makes the skin more susceptible to injury from exposure to irritants particularly related to urine and feces. A gentle cleansing routine, frequent diaper changes, and a thick barrier cream help control this condition. Irritant diaper dermatitis should be distinguished from other skin conditions that may develop in this sensitive area.     

Einfluss von Babyschwimmen und Babypflegelotion auf die Hautbarriere von 3–6 Monate alten Säuglingen

Background: Skin care is important especially in infancy as the skin barrier matures during the first year of life. We studied the effects of baby swimming and baby lotion on the skin barrier function of infants. Subjects and methods: 44 infants aged 3–6 months were included in this mono‐center prospective study. The healthy infants swam four times and were randomized to group_L: baby lotion was applied after swimming all over the body and to group_WL: no lotion was used. Transepidermal water loss, stratum corneum hydration, skin‐pH and sebum were measured on four body regions using non‐invasive methods. Results: In group_L, sebum and pH remained stable. In group_WL, significant decrease in sebum was noted on forehead and thigh, and for pH on thigh and buttock. Group_L had fewer infants with at least one adverse event compared to group_WL. Location‐dependent gender differences in skin barrier function were observed. Conclusions: Reaction of skin barrier function to baby swimming and skin care regimens showed typical regional variability between body areas. Influence of baby lotion on skin barrier and gender differences in skin functional parameters were demonstrated for the first time in healthy infants participating in baby swimming.     

Clinical Demonstration of Skin Mildness and Suitability for Sensitive Infant Skin of a New Baby Wipe

Abstract: Background: A cleansing baby wipe with sufficient pH buffering capacity may help to restore the pH balance of skin following exposure to urine and feces in the diaper environment and maintain skin health. Objective: To evaluate the skin effects of a novel baby wipe formulation with increased pH buffering. Subjects and Methods: A series of clinical studies was designed and conducted to evaluate the skin effects of the new baby wipe, including a 21‐day cumulative skin irritation patch study in adults (n = 31), a 4‐week study in babies with medically confirmed atopic dermatitis (n = 32), a 2‐week study comparing skin pH of babies (n = 15) following use of wipes compared with water and wash cloth, a series of clinical skin pH measurements following fecal exposure and subsequent cleaning with different products (n = 50) and a study evaluating comfort of product application on irritated skin (n = 31). Results: The wipes formulation was well‐tolerated, even in babies with atopic dermatitis, and was more comfortable versus water and washcloth. Increased buffering capacity of a wet wipes lotion helps to maintain a physiologically balanced skin pH value in the diaper region.     

Skin care of the diaper area

Abstract:  The skin of the diaper area has special needs for protection from the irritating effects of urine and feces and prevention of diaper dermatitis. These needs include products such as diapers that absorb the excreta, as well as products for cleansing and conditioning the skin. A number of factors play a role in development of diaper dermatitis, including prolonged exposure to excreta, alterations in skin pH or increased hydration, and changes in skin microbial flora. Recent decades have seen great improvements in our understanding of these factors and our ability to develop new and better products to protect baby skin. Better diaper designs and the development of pH-buffered baby wipes have improved the care of skin in the diaper area. Continuing research offers the promise of new products with additional benefits for caregivers and infants.     

Comparison of Disposable Diapers with Fluff Absorbent and Fluff Plus Absorbent Polymers: Effects on Skin Hydration, Skin pH, and Diaper Dermatitis

Diaper dermatitis results from the action of a number of physical and chemical factors on the skin. While its etiology is complex, there is agreement that prolonged contact between wet diapers and the skin leading to excessive hydration of the stratum corneum and reduced barrier function is a primary factor. Recent research also indicates that pH elevation resulting from ammonia production increases the probability of skin damage due to fecal enzyme activity. New diapers containing absorbent polymers blended with cellulose fluff in the absorbent core have been developed. The absorbent polymer binds fluids and controls pH in the diaper environment. To assess the effectiveness of these diapers, a clinical study was conducted with approximately 150 infants over 15 weeks, using fluff diapers and absorbent polymer diapers. The results clearly showed that the diapers with absorbent polymer provide a better skin environment than those with fluff only with respect to lower skin wetness and pH control (instrumental measurements). In addition, the clinicians' grades indicated a directional reduction in diaper rash severity.     

Neonatal intensive care practices and the influence on skin condition

Background Premature skin has a thinner epidermis with a poorly formed stratum corneum (SC) barrier compared to full term skin. Poor skin integrity increases the risk of exposure to irritants and infectious agents. Interventions that facilitate skin maturation are essential. Objective The objective was to examine the effects of prematurity and time from birth on SC maturation and to identify factors that impact skin condition. Methods A retrospective review was conducted among 130 NICU patients. Skin regions were evaluated for erythema, rash, integrity and function. The effects of gestational age, time from birth, stool exposure, nutrition and diagnosis were examined. Results Three groups emerged: (i) premature and <38 weeks adjusted age; (ii) premature and >38 weeks adjusted age; and (iii) full term. Surprisingly, the premature infants exhibited lower perineal irritation and greater SC integrity (lower transepidermal water loss) than full terms (P < 0.05). Group 2 had a longer time before the first skin‐stool contact. Chest skin pH showed maturational changes for Group 1 (P < 0.05) but did not change for premature Group 2 who was older at enrollment. Erythema was lower for infants using elemental formulas or total parenteral nutrition. Conclusions Premature infants with early stool contact and high exposure, full term infants, and patients with congenital diaphragmatic hernia or trisomy 21 are at high risk for skin compromise and may benefit from prophylactic interventions to minimize compromise. Low stool exposure and greater time before the first stool contact appear to be protective against skin compromise.     

Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis

Cloth diapers, cellulose core diapers (conventional disposable diapers), and cellulose core diapers containing absorbent gelling material were examined for their effects on diaper rash and skin microbiology of normal infants and infants with atopic dermatitis in a 26-week double-blind clinical trial. Infants with atopic dermatitis wearing the diapers containing absorbent gelling material had significantly lower diaper rash grades than infants with atopic dermatitis wearing cloth diapers at five of eight grading visits. Infants with atopic dermatitis wearing conventional cellulose core diapers had statistically less rash at one of eight visits. There was no statistically significant difference between diaper types at three of the eight visits. At no time did the cloth group have less diaper rash than the conventional cellulose or absorbent gelling material disposable diaper group. A statistical correlation between the severity of general atopic dermatitis outside the diaper area and the diaper rash condition under the diaper occurred only in the atopic dermatitis group wearing cloth diapers. Isolation of microorganisms from the intact, uninvolved skin surface both inside and outside the diaper showed no biologically significant changes in the presence or numbers of selected skin organisms. Repeated isolation, at multiple grading visits of Staphylococcus aureus from uncompromised skin inside the diaper area was infrequent but correlated with the diagnosis of atopic dermatitis when observed.     

Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition

Disposable infant diapers with absorbent gelling material (cross-linked sodium polyacrylates) incorporated into the core were clinically evaluated for their effect on infant skin condition. Absorbent gelling materials tightly hold water and provide pH control by a buffering capacity as well as by helping to segregate urine apart from feces. Four clinical studies were conducted with each following a rigid protocol that controlled for variables of diet and age in addition to the diaper material that may influence the development of diaper dermatitis and helped to control for any inherent bias in the study. This allowed for the controlled assessment of skin condition with respect to diaper type. Absorbent gelling material-containing disposable, conventional (100% cellulose core) disposable, and home-laundered cloth diapers were test products. In these studies 1614 infants were initially enrolled with 522 of them assigned to absorbent gelling material disposable, 738 to conventional disposable, and 354 to home-laundered cloth diapers. Objective measurements of skin wetness (transepidermal water loss) and skin pH, as well as double-blind grading of diaper dermatitis, were the measures of skin condition. Absorbent gelling material disposable diapers were associated with significantly reduced skin wetness, closer to normal skin pH, and lower degrees of diaper dermatitis when compared to conventional disposable or home-laundered cloth diapers. The results are consistent with the hypothesis that better control in the diaper area of skin wetness, skin pH, and the prevention of the mixing of urine and feces produces a better diaper environment.     

Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study

Abstract: Improving skin barrier function and moisturizing without irritation are important components of managing patients with atopic dermatitis. This study evaluated the safety and tolerability of a body wash and moisturizer regimen for infants and toddlers with atopic dermatitis. This was an open‐label study involving 56 children (3–36 months old) with a history of atopic dermatitis. The skin care regimen (Cetaphil Restoraderm Skin Restoring Body Wash and Cetaphil Restoraderm Skin Restoring Moisturizer; Galderma Laboratories, L.P.) was used at least once daily, but no more than twice daily, for 4 weeks. The primary variable of interest was the worst postbaseline scores for local tolerability (expressed as success or failure) using a 4‐point scale for each component (erythema, edema, scaling and dryness, rash, and signs of discomfort upon application). Assessments of moisture content of the stratum corneum and transepidermal water loss were also performed. Fifty‐three children completed the study. The percentage of subjects with no erythema increased from 33.9% to 50.0% by Week 4. The percentage of subjects with no scaling or dryness increased from 58.9% to 85.2% at Week 4. A statistically significant increase in corneometry from baseline (p < 0.001) and a statistically significant decrease in transepidermal water loss (p = .009) were observed. The body wash and moisturizer regimen was safe and well tolerated and improved hydration and skin barrier function in infants and toddlers as young as 3 months of age with a history of atopic dermatitis.     

The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis*

Background In adults and children aged > 2 years, systemic absorption of tacrolimus from tacrolimus ointment is very low. In this study, the pharmacokinetics of tacrolimus 0.03% ointment were investigated in infants aged 3–24 months. Methods The pharmacokinetics of tacrolimus after first and repeated topical application of tacrolimus 0.03% ointment were evaluated in 53 infants (age, 3–24 month) with atopic dermatitis requiring treatment with mid‐potency topical corticosteroids. Patients were grouped according to percentage of body surface area affected (Group 1: 5–20%; Group 2: > 20–40%; Group 3: > 40%). After stratification, patients were randomized (double‐blind) to receive once‐daily or twice‐daily tacrolimus 0.03% ointment. Results Blood samples taken on days 1 and 14 (first and last application) showed minimal systemic tacrolimus exposure. Overall, 97% of blood samples assayed contained tacrolimus concentrations < 1 ng/ml, and 20% were below the lower limit of quantification (0.025 ng/ml). Systemic tacrolimus exposure was variable, but tended to increase as the treated body surface area increased. Mean apparent half‐life of tacrolimus was 80 ± 35 h (range: 25–175 h). Most patients experienced substantial clinical improvement in their atopic dermatitis. There were no clinically significant changes in laboratory values, and the most frequently reported adverse events were minor infections and local skin irritations. Conclusions Tacrolimus 0.03% ointment in infants is associated with very low systemic exposure to tacrolimus. Treatment was well tolerated and led to considerable clinical improvement.