Continuous topical administration of a petrolatum formulation by a novel disposable diaper. 1. Effect on skin surface microtopography

BACKGROUND: Cutaneous problems are commonly associated with the use of diapers. Aiming to help reduce them, we have explored the use of the inner layer of diapers as a means to deliver to the skin dermatological formulations intended to help protect it from overhydration and irritation. OBJECTIVE: To determine the feasibility of using the inner layer of the diaper as a vehicle for topical delivery of a petrolatum-based formulation and to determine its impact on skin surface microtopography. METHODS: Two independent, blinded, randomized clinical trials were conducted, on children 16-24 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 transfer of formulation to the skin and skin surface microtopography. RESULTS: During normal diaper use, formulation transfer from the diaper to the skin occurred in a cumulative, time-dependent manner and use of the formulation-treated diaper was associated with significant reductions in skin surface roughness compared to the control diaper. CONCLUSIONS: The results demonstrated the feasibility and skin surface benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. This unprecedented dosimetric approach offers new avenues to reduce further the dermatological problems commonly associated with diaper use.     

A noninvasive method to assess skin irritation and compromised skin conditions using simple tape adsorption of molecular markers of inflammation

Background/aims: We have developed a simple noninvasive method to assess inflammatory changes in human skin, even in the absence of visible clinical irritation. Our approach is based on a simple tape (Sebutape^®) adsorption method to recover molecular mediators of skin inflammation (e.g., cytokines). This procedure has been used to investigate baseline cytokine levels on skin, to assess normal skin condition and to evaluate changes due to chemical insult, existing dermatitis, or sun exposure. Methods: In clinical studies, Sebutape was applied to normal appearing uncompromised skin, as well as to compromised (diaper or heat rash), chemically treated (sodium laurel sulfate), or sun-exposed skin. Sebutape was applied to the skin for a 1 min collection interval. Tapes were extracted in saline using a 10 min sonication, and the extracts were analyzed for human interleukin-1α (IL-1α), IL-1 receptor antagonist (IL-1RA) and IL-8 using commercial immunoassay test kits. The cytokine levels recovered from each tape extract were normalized to total protein (TP) levels. In infant product use tests, the severity of skin irritation (diaper and heat rash or erythema) was also assessed using a visual grading scale. Results: The method itself caused minimal, if any, skin damage. Additionally, Sebutape was shown to quantitatively adsorb detectable levels of cytokine from normal-appearing (control) or compromised (e.g., rashed or chemically treated) skin. In infant studies, significant increases in IL-1α levels were found in skin exhibiting diaper rash, heat rash and erythema compared with normal appearing control skin sites. When these results were normalized to total protein levels recovered from each tape, the significance was maintained. A positive correlation (r²=0.82) existed between IL-1RA levels and diaper rash severity. Significant increases in IL-8 levels were recovered from diaper rash versus control skin sites. There were differences in baseline cytokine levels in normal skin related to body site and sun exposure. The IL-1RA/IL-1α ratios for sun-exposed skin of the face and lower leg were significantly (P<0.05) higher (3–6-fold) than those for skin sites that typically receive minimal sun exposure (i.e., underarm, upper leg and upper back). There was a significant increase in IL-1α and a directional increase in IL-8 levels in adult skin sites treated with the irritant, sodium lauryl sulfate, even in the absence of visible skin irritation (erythema). Conclusion: Our results demonstrate that this method is a useful noninvasive technique for assessing skin inflammatory events. In addition, the method is simple and easily applied in a clinical setting, whether on infants or adults.     

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.     

Hydrogel barrier/repair creams and contact dermatitis.

BACKGROUND: Barrier creams are important to protect the skin in occupations with chemical exposure. The value of hydrogels in barrier creams has never been studied. OBJECTIVE: The purpose of this study was to evaluate the current technology in barrier cream formulation and explore the utility of hygrogels in skin protection. METHODS: A total of 80 men, women, and children between the ages of newborn to 80 years >were studied with the following dermatologic conditions: household hand dermatitis (21), occupational hand dermatitis (18), latex glove irritant contact dermatitis (9), diaper dermatitis (5), cutaneous wounds (17), and allergic contact dermatitis (ACD) (10). In this study, the investigators used a split body approach, in a double-blind randomized fashion, where one body site was treated with a traditional petrolatum-based cream while the other body site was treated with a hydrogel-based barrier/repair cream. Both subject and investigator assessments were recorded by questionnaire. RESULTS: The hydrogel barrier/repair cream showed better skin improvement than the petrolatum-based cream in both subject assessment (62%, P =.0048) and investigator assessment (75%, P =.0000003). CONCLUSION: Hydrogel barrier/repair creams might represent a new, effective approach to skin protection.     

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.     

Diaper Dermatitis: Frequency and Severity Among a General Infant Population

The frequency and severity of diaper dermatitis was measured among a midwestern suburban population of 1089 infants ranging in age from 1 to 20 months. No diagnosis of specific etiology was made. Fecal samples were collected and analyzed for Candida albicans, and information on family characteristics, infant diet, general health, history of rash, and diapering habits and practices was collected by questionnaire. The distribution of the severity of observed diaper rash can be described as a logarithmic-normal function, implying several multiplicative causative factors. Within the total severity range, there appear to be three subcategories of diaper rash, differing in some manner, perhaps reflecting different etiologies. The frequency of observed diaper rash was a function of the maturity of the infant, reaching a maximum around 9 to 12 months of age. The prevalence of severe rash correlated with the presence and level of fecal C. albicans. Infants diapered exclusively in disposable diapers showed less rash (P less than 0.001) than those diapered exclusively or sometimes in cloth diapers.     

Relationship Between Skin Barrier Function in Early Neonates and Diaper Dermatitis During the First Month of Life: A Prospective Observational Study

Diaper dermatitis, a common skin problem in newborn infants, is characterized by poor functioning of the skin barrier. This study aimed to elucidate the relationship between skin barrier function in 4‐day‐old infants and the occurrence of diaper dermatitis during the first month of life. We recruited healthy Japanese infants born at 35 weeks of gestation or more. We measured indicators of skin barrier function, namely skin pH and transepidermal water loss, in 4‐day‐old infants on four places on the body. Individual characteristics were recorded from the infants' medical charts. The presence of diaper dermatitis was judged using the diaper rash and erythema scoring scale, which was based on daily recording of the infants' skin condition by their parents. The parents also filled out a questionnaire 1 month after birth regarding stool frequency and certain external factors. The association between diaper dermatitis and skin barrier function was assessed using multiple logistic regression analysis. The analysis included 88 infants. The incidence of diaper dermatitis was 25.0%. After adjusting for stool frequency for 1 month we noted that high pH on the inner arm skin in 4‐day‐old infants increased the risk of diaper dermatitis during the first month of life (adjusted odds ratio 3.35 [95% confidence interval = 1.12, 10.04]). Early neonatal skin pH may predict the risk of diaper dermatitis during the first month of life. Our results may be useful in devising strategies to prevent diaper dermatitis.     

Diaper dermatitis-frequency and contributory factors in hospital attending children

Abstract:  The incidence and prevalence of diaper dermatitis varies widely between published studies. It is a condition which causes considerable parental anxiety. To better understand the frequency of diaper dermatitis, treatment practices, and the current importance of previously identified etiologic factors, a questionnaire survey of parents who had children wearing diapers ( n  = 532) attending a large United Kingdom district general hospital was undertaken. At the time of survey, only 16% of the study population had diaper dermatitis. Forty-eight percent of the study population had never had an episode of diaper dermatitis. In a multivariate analysis, current diaper dermatitis was independently associated with four factors: presence of oral thrush, number of previous episodes, frequency of diaper changes, and diarrhea. Recurrent episodes of diaper dermatitis were associated with increasing age, lack of barrier cream use, current diaper rash, and frequency of diaper changes. In the majority of children with diaper dermatitis at the time of survey, treatment had been instituted in the community. Diaper dermatitis usually presents and is treated successfully outside the hospital setting and is not a common clinical problem in secondary care.     

Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0.25%

Diaper dermatitis, an acute inflammation of the skin in the diaper area, is the most common dermatologic disorder of infancy. This placebo-controlled, randomized, double-blind, parallel-group trial compared the efficacy and safety of miconazole nitrate 0.25% in a zinc oxide/petrolatum base with that of the ointment base alone in treating acute diaper dermatitis in infants and evaluated the role of Candida albicans in the response to treatment. Infants age 2-13 months with diaper rash were treated with either miconazole nitrate 0.25% (N = 101) or ointment base (N = 101) for 7 days. Although improvement in rash from baseline was seen in both treatment groups on days 3, 5, and 7, patients receiving miconazole nitrate 0.25% had significantly fewer rash sites and lower mean total rash scores on days 5 and 7 (p < 0.001). In the miconazole nitrate 0.25% group, improvement was most marked among those with moderate or severe diaper dermatitis at baseline and among patients whose baseline rashes were positive for C. albicans. Treatment with miconazole nitrate 0.25% was as safe as with ointment base alone. Miconazole nitrate 0.25% ointment is a safe and effective treatment for diaper dermatitis in infants.     

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.     

The development of a nomogram model for the individualized prediction of diaper dermatitis risk in pediatric hospitalized children aged 1–36 months

Aims and objectiveTo develop a nomogram model for individualized prediction of diaper dermatitis in pediatric hospitalized infants and toddlers aged 1–36 months.BackgroundDiaper dermatitis is a common skin health problem in pediatrics, which brings pain and discomfort to the child. However, there is a scarcity of risk prediction tools for diaper dermatitis in infants and toddlers hospitalized in pediatrics.DesignA cross-sectional study.Methods210 cases each for caregivers and hospitalized children aged 1–36 months were selected as the research objects. A prediction nomogram model was established based on the risk factors according to the results of univariate analysis and multivariate logistic regression analysis. The predictive performance of the nomogram model was evaluated by discrimination and calibration. The clinical utility of the model was evaluated by decision curve analysis. This study was reported using the TRIPOD checklist.Results41 hospitalized children with diaper dermatitis with a prevalence of 19.52%. The risk factors included: age in months, diarrhea, history of diaper dermatitis, without prophylactic application of buttock protection products, frequency of diaper change per day ≤6.6 times, and the level of caregivers’ knowledge of infantile diaper dermatitis. The results showed that the C-index of the nomogram model was 0.891(95% CI: 0.832, 0.950), the calibration curve manifested a satisfactory consistency, and the net benefit was satisfactory.ConclusionsThe nomogram has a good predictive ability and satisfactory clinical utility, which is useful for pediatric medical staff screening high-risk patients with diaper dermatitis.Relevance to clinical practiceThe prediction nomogram model can help pediatric medical staff to calculate the risk probability of diaper dermatitis in pediatrics, formulate interventions timely, and optimize pediatric DD standardized care protocols.No patient or public contributionthe children's caregivers enrolled in this study only for the data collection.     

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.     

Towards an international language for incontinence‐associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries

The best way to prevent and treat diaper dermatitis (nappy rash) in babies has been the topic of research for decades. However this skin problem can also occur in adults, where it is known as incontinence‐associated dermatitis (IAD). It is a specific type of irritant contact dermatitis ‐ a type of eczema caused when contact with something causes irritation (rather than an allergy), in this case prolonged contact of the skin with urine or faeces. It is hard to know exactly how many people suffer from IAD as there is not one set of internationally agreed diagnostic criteria (e.g. a list of specific symptoms and criteria that identify the disease) that help differentiate it from other skin disorders with similar symptoms, such as pressure ulcers. Ten different instruments / tools (meaning ways of diagnosing and ranking the severity of the disease) exist, but some are complex, and a single one is needed to make sure study results are comparable. Therefore, a group of 34 experts in 13 countries worked together to develop a tool that was started in 2015, called GLOBIAD. It was then translated into 14 different languages. Its accuracy was tested by asking 823 experts in 30 countries to categorize 34 photos of IAD using GLOBIAD to see if their results matched. The study found that the development of the GLOBIAD is a major step towards a better systematic assessment of IAD in clinical practice and research worldwide. However, further validation is needed.     

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.     

Microbiological aspects of diaper dermatitis

BACKGROUND: The microbiological basis of diaper dermatitis is not clearly elucidated, although a better knowledge of microbial colonisation can be of importance with regard to an adequate treatment. OBJECTIVE: To investigate the relevance of candida sp. and Staphylococcus aureus colonisation in diaper dermatitis and to determine the correlation between the extent of colonisation and the severity of disease. METHODS: Growth of candida sp. and S. aureus in the perianal, inguinal and oral regions was determined by positive/negative and semi-quantitative analysis in an open, multi-centre (n = 3) study. Forty-eight children with healthy skin and 28 with diaper dermatitis were analysed. The severity of diaper dermatitis was assessed using a total symptoms score. RESULTS: Colonisation by candida sp. was significantly more frequent in children with diaper dermatitis as compared to those with healthy skin (perianal 75 vs. 19%; inguinal 50 vs. 10%; oral 68 vs. 25%, p < 0.0003), whereas colonisation by S. aureus at the 3 swab locations was not different (p > 0.34). There was a highly significant, positive correlation between severity of disease and extent of candida sp. colonisation at all swab locations. CONCLUSIONS: Limited microbial colonisation in diaper dermatitis is of questionable relevance, but extensive colonisation seems to aggravate the symptoms; therefore, we suggest that semi-quantitative evaluation should be preferred to the positive/negative assessment for a differential diagnosis.     

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.     

The frequency of common skin conditions in preschool-age children in Australia: atopic dermatitis

OBJECTIVE: To determine the prevalence and severity of atopic dermatitis in a stratified cross-section of preschool-age children examined throughout Victoria, Australia. DESIGN: A cross-sectional skin survey using a selected cluster sample of the various centers throughout Victoria. SETTING: The study population included Victorian children attending child-care centers, preschools, and Maternal and Child Health Centres, with the reference population being Australian children aged 5 years and younger. PARTICIPANTS: Of 1634 potential participants, 1116 children (68.3%) were examined. INTERVENTION: A dermatologist performed a total skin examination, including head and neck, limbs, and trunk, on all children. The diaper area was examined in children younger than 12 months. MAIN OUTCOME MEASURE: All parents were administered a questionnaire to elicit demographic information, history of skin conditions, and family history of skin problems or related diseases. The examiner recorded the presence, site, and severity of atopic dermatitis for calculation of age- and sex-specific prevalence rates. RESULTS: The age- and sex-adjusted point prevalence was 30.8% (95% confidence interval [CI], 28.0%-33.5%). Most children (63.7%) were classified as having minimal or mild disease. Only 5.8% of children with atopic dermatitis did not have face or flexural involvement. Of the 237 children with atopic dermatitis and information available, 209 used 1 or more products to treat their condition. CONCLUSIONS: Atopic dermatitis is common, decreasing in prevalence after the first 3 years of life. Most children have mild disease requiring little if any treatment, and much could be prevented with simple measures. Educational programs directed at those caring for preschool-age children that provide information on simple preventive measures, where practical, and sources of advice for treatment, if necessary, could substantially reduce the morbidity of this condition in predisposed children.     

Urinary ammonia and ammonia-producing microorganisms in infants with and without diaper dermatitis

Free ammonia was determined in diaper squeezings from 26 infants with "ammoniacal dermatitis" and in 82 controls. No significant difference was found (402 ppm in diaper dermatitis compared to 465 in controls). The groups did not differ with regard to the incidence of organisms capable of splitting ammonia from urea. Experimental application of highly ammoniacal urine on intact infant and adult skin failed to provoke a dermatitis. Erythema could be induced only when ammoniacal urine was applied occlusively to scarified skin. These findings do not support the notion that ammonia is a primary factor in common diaper rash, but do not exclude a possible role for further irritation in an already existent condition.     

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.