Rapid Improvement and Protective Effects of an Almond Oil-Based Ointment for Diaper Dermatitis

November 2016 | Volume 15 | Issue 11 | Supplement Individual Articles | 86 | Copyright © November 2016

Peter A. Lio MD

Northwestern University Feinberg School of Medicine and Medical Dermatology Associates of Chicago, Chicago, IL

Abstract
INTRODUCTION AND OBJECTIVES: Newborns and babies are at risk of developing diaper dermatitis due to constant occlusion and exposure to irritants such as urine and feces. The aim of this study was to evaluate the clinical effectiveness of an almond oil-based ointment on diaper dermatitis in infants. MATERIALS AND METHODS: A multicenter open-label trial of 60 infants (1-36 months) with a known history of recurrent diaper dermatitis was performed. The infants were clear at the time of enrollment. Inclusion criteria was a minimum of 3 episodes of rashes in the diaper area in the four weeks prior to enrollment. The almond oil-based ointment was used daily after each diaper change over 28 days, and data was recorded by the users (persons who applied the product) with daily report logs for the study duration including presence of diaper dermatitis, severity, as well as reports of teething and/or diarrhea. During each visit, a clinical evaluation was performed by an assessor (dermatologist or pediatrician) recording the degree of erythema, skin dryness, skin roughness to the touch, and skin suppleness using a scoring scale from 0 (null) to 9 (very severe). The users also performed an evaluation on product effectiveness and cosmetic qualities. RESULTS: Clinical evaluations showed no erythema, a signi cant decrease (P less than 0.01) in skin dryness, roughness, and a signi cant in- crease (P less than 0.01) in skin suppleness after 28 days of product application compared to initial state. During the course of the study, 90% of the subjects showed a decrease in frequency or total absence of diaper dermatitis. One-hundred percent of users rated the product to have a pleasant texture, a good protective effect, spreads easily, and does not irritate the skin. The scent was judged as pleasant by 95%, and for 75% of those applying the product, the texture was described as non-oily. CONCLUSIONS: For newborns and infants regularly developing diaper dermatitis, the almond oil-based ointment appears to confer a protective effect from future episodes of diaper dermatitis, improves dryness and suppleness of skin, and is cosmetically acceptable by the users. J Drugs Dermatol. 2016;15(suppl 11):s86-90

INTRODUCTION

Diaper dermatitis (DD) is a term used by clinicians to describe a wide range of inflammatory processes that occur in the diaper area.1 DD is probably the most common cutaneous disorder in infancy and early childhood and is thought to account for nearly 20% of childhood dermatology visits and in up to 25% of children.1,2,3 There are a number of causes of DD including candida infections, allergic reactions, seborrheic dermatitis, bacterial infections, and rarer conditions such as zinc deficiency and Langerhans cell histiocytosis, but the most common cause by far is irritant dermatitis, fueled by contact with urine and feces.4The Berg model of diaper dermatitis outlines the pathophysiology of irritant contact dermatitis in the diaper area and consists of the following contributing factors:
  1. Increased moisture in the diaper area created by the occlusive effect of the diaper combined with the presence of feces and urine
  2. Maceration of the skin and disruption of the skin barrier due to friction within the skin folds in the area
  3. pH imbalance from the proteases and lipases found within feces as well as with bathing products
  4. This elevated (more basic) pH results in abnormal skin flora, which in turn makes the skin more susceptible to infection by bacteria and fungus.5 
Barrier creams, ointments, and pastes are often the first line treatments for DD and attempt to provide a water-repellent emollient or protective ointment to the skin. 6 The rationale for using a barrier cream or paste in the treatment or prevention of diaper dermatitis is that a thick occlusive cream or paste will help protect the skin from the increased moisture in the environment and thus support epidermal barrier function. While diaper care procedures aim to support skin barrier function, little is known about the effect of diaper creams on skin barrier function in infants. A study in 2014 investigated the skin barrier
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function of diapered and non-diapered skin areas affected by DD in healthy infants and found that areas with DD had higher TEWL and skin pH than unaffected skin areas. Moreover, infants treated with diaper cream had lower TEWL and, interestingly, lower stratum corneum hydration, which may demonstrate protection against maceration. 7  The aim of this study was to evaluate the clinical effectiveness and cosmetic acceptability of an almond oil- and soybean oil-based ointment on DD in children with recurrent irritant diaper dermatitis.Almond oil has been used for its numerous health and beauty benefits since ancient times, with many traditions utilizing almond oil to treat dry skin conditions such as psoriasis and eczema, improve skin complexion, and promote soft healthy skin. 8 Almond oil remains sought-after for its rich concentration of oleic and linoleic essential fatty acids, and is used in the cosmetic industry for its penetrating, moisturizing, and restructuring properties. Almond oil is a non-toxic, non-irritating, nonsensitizing and non-comedogenic, readily emulsifiable ester, which possesses some of the following properties and attributes:
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There is theoretical concern for allergic potential as it is derived from a tree nut, however, only 1 known case of IgE sensitization is reported. 9  Glycine Soja Oil (Soybean Oil) is derived from the seeds of the soya plant Glycine max. Soy extracts can be found in many cosmetic products, as numerous biologically active compounds have been identified in soybean. 10 Lipids, lecthins, and phytosterols enhance the skin barrier, while isoflavones impart an antioxidant effect. 11 In vitro studies have shown that soybean extracts stimulate collagen synthesis, initiate the elastin repair process, inhibit melanosome transfer, and have antioxidant/anti-inflammatory action; these properties reflected in the clinical benefits of topical soy formulations: anti-inflammatory, moisturizing, photorejuvenation/photoprotection, amelioration of fine lines, and skin lightening/brightening. 10  
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This was a multicenter open-label trial of 60 infants and children (1 to 36 months) with a known history of recurrent mild-to-moderate diaper dermatitis. The investigator group comprised 8 dermatologists and 2 pediatricians. Inclusion criteria was a minimum of 3 episodes of rashes in the diaper area in the four weeks prior to enrollment but subjects were clear at the time of enrollment. The almond oil-based ointment was used daily after each diaper change over 28 days, and data was recorded by the users (person who applied the product) with daily report logs for the study duration including presence of diaper dermatitis, severity, as well as reports of teething and/or diarrhea. During each visit, a clinical evaluation was performed by an assessor (dermatologist or pediatrician) recording the degree of erythema, skin dryness, skin roughness to the touch, and skin suppleness using a scoring scale from 0 (null) to 9 (very severe). The users also performed an evaluation on product effectiveness and cosmetic qualities. 

RESULTS

All 60 subjects completed the study. Fifty-three percent were female and forty-seven percent were male. The subjects’ age ranged from 33 days to 3 years with an average of 11.1 months. The average number of diaper dermatitis episodes was 4.1 and the average duration for the study was 30 days. An average of 6.3 applications of the ointment per day was recorded (Table 1).Clinical evaluations showed no erythema, a significant decrease (P<0.01) in skin dryness, roughness, and a significant increase (P<0.01) in skin suppleness after 28 days of product