A Natural Cream-to-Powder Formulation Developed for the Prevention of Diaper Dermatitis in Diaper-Wearing Infants and Children: Barrier Property and In-Use Tolerance Studies

May 2018 | Volume 17 | Issue 5 | Original Article | 566 | Copyright © 2018

Hemali B. Gunt PhD,a Stanley B. Levy MD,b Celeste A. Lutrario BSa

aResearch and Development, Burt’s Bees Inc., Durham, NC bDuke University School of Medicine, Durham, NC

Abstract

Introduction: Diaper dermatitis is a common condition that develops in the diaper area due to factors such as elevated moisture, increased skin surface pH, and exposure to irritants from urine and feces. These factors suggest interventions to prevent or treat diaper dermatitis such as exposing the skin to air, frequent diaper changes, and thorough cleansing of the diaper area. Barrier creams and powders also have a role in preventing and treating diaper dermatitis. We developed a cream-to-powder product with a formula based on corn starch and other natural ingredients for use in the diaper area. Methods: Dye exclusion study: The barrier properties of the cream-to-powder product were assessed using a dye exclusion protocol. Skin color at treated and untreated forearm sites was measured at baseline and after exposure to crystal violet stain. The cream-to-powder product’s ability to inhibit the water-soluble dye from reaching the skin was judged by comparing color changes at the treated and untreated sites. Tolerance-in-use study: The safety of the cream-to-powder product was assessed in a four-week tolerance-in-use study conducted in a group of 52 diaper-wearing infants and toddlers. Subjects’ parents/guardians applied the cream-to-powder product at each diaper change. A pediatrician judged safety endpoints of erythema, dryness, and edema in the diaper area at baseline and at study end. Parents/guardians also completed a questionnaire at study end. These studies have complied with Good Clinical Practices (GCP/ICH). Outcomes: The cream-to-powder product prevented about 70% of the test dye from reaching the skin surface, demonstrating its ability to supplement the skin barrier. The tolerance-in-use study showed no statistically significant changes in any of the safety endpoints; there were no adverse events. Parents/guardians responses to the cream-to-powder product were overwhelmingly positive. Taken together, these results support that the cream-to-powder formulation is safe and effective for helping to prevent diaper dermatitis. J Drugs Dermatol. 2018;17(5):566-570.

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INTRODUCTION

Diaper dermatitis, also known as diaper rash, is an acute inflammation of the skin that occurs in the area normally covered by the diaper. The condition is not life-threatening and is often self-limited but nonetheless causes discomfort for the affected child and anxiety for the parents or caregiver.1,2 Changes in diaper technology, ie, the evolution from cloth diapers to diapers that are based on superabsorbent polymer technology, have reportedly reduced the incidence and severity of diaper dermatitis but it remains a relatively common condition.3–5 Twenty-five percent of twelve thousand parents of newborns surveyed in Great Britain reported diaper rash within the four-week period after birth.2 Others report a prevalence between 7% and 65%, with a peak between the ages of 6 and 12 months.1,6 The American Academy of Pediatrics estimates that “more than half of children between 4 and 15 months of age will develop diaper rash at least once in a two-month period.”7Several factors contribute to diaper rash development including overhydration of the skin, increased local pH, and exposure to irritants from urine and feces.1,2,4–6,8 Even in the absence of excreta, the barrier formed by a diaper overlaying the skin will increase skin hydration by trapping water that normally escapes from the skin surface via transepidermal water loss (TEWL). The increase in hydration also increases the skin’s permeability and susceptibility to microbial growth. Skin surface pH is slightly acidic, which creates an environment that is optimum for stratum corneum homeostasis and microbial growth inhibition.9,10 The presence of urine or feces in the diaper increases the pH in the diaper environment, which increases the activity of fecal enzymes that can attack the skin’s surface.2–4,8,11–13 These factors macerate the stratum corneum, which increases the skin surface coefficient of friction, makes the skin susceptible to abrasive damage, increases irritant susceptibility, and increases the risk of infection.1,2,4,6,8,14The factors responsible for diaper dermatitis can be prevented or treated. Interventions include removing the diaper for short periods of time to allow skin to dry, changing the diaper frequently to minimize contact with excreta, cleansing the diaper area thoroughly with water or a mild cleanser, and using

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