Wet wipes are a relatively new consumer product. In 1957, Nice-Pak's Wet-Nap1 was introduced as the first disposable cleansing wipe. Its use expanded quickly, thanks to an order from Kentucky Fried Chicken (KFC), which wanted to provide customers with a handy hygiene option for greasy fingers.1 It was not until the 1990s that Kimberly-Clark introduced a disposable wipe for use on babies, the well-known Huggies brand.2 Now, hundreds of wipes including facial, hand, and personal hygiene wipes are available. Wipe use has also been on the rise; 66% of Americans indicated wipe use in 2004, which increased to 71% in 2008.3 Although wipes have incorporated convenient cleansing into everyday life, they have also introduced a new source of allergen exposure.
Wipes are generally thought to be safe to use, even on infant skin,4,5 but the prevalence of allergic contact dermatitis from wipe sources is unknown. In the last few decades, several reports of wipe-associated dermatitis have been published6–17 involving a total of 43 patients. This study aimed to determine the prevalence of allergic contact dermatitis associated with wipes and the most commonly responsible allergens in a referral patch test population.
This study was approved by the Minneapolis Veterans Affairs Medical Center's Human Studies Subcommittee. Methods for patch testing and data recording by the North American Contact Dermatitis Group have been previously reported.18–20 Patients were tested to a screening series of 70 allergens. Results were verified before being manually entered into a central database.18 Information recorded in the database included the following: patient age, sex, race, atopic history (hay fever, eczema, asthma), occupational relatedness of dermatitis, site(s) of dermatitis (3 sites maximum), strength of reaction and source of allergen (triple-digit code), clinical relevance of allergy, and the presence of other relevant non–North American Contact Dermatitis Group (NACDG) allergens (though not the specific allergen name) and source of those allergens (triple-digit code). Only 1 source code was recorded per allergen, so if an allergen was present in multiple sources, the source that was most likely to be clinically relevant was entered. A single source for irritant contact dermatitis was also recorded, if present.
This analysis focused on reactions associated with the triple-digit source code of “wipe,” which was added at the end of 2010. The code for wipes does not differentiate between different forms of personal care wipes (eg, facial wipes, hand wipes, personal hygiene wipes) but does exclude household (for nonskin use) cleaning wipes.
The clinical relevance of an allergen was coded as definite (use test with the wipe was positive or a patch test to the wipe was positive), probable (the antigen could be verified as present in the wipe and clinical presentation was consistent), possible (patient was exposed to circumstances in which skin contact with wipes known to contain the allergen was likely to occur), past, unknown, not applicable, or not tested.18
Subjects included in the study underwent patch testing with a member of the NACDG between January 1, 2011, and December 31, 2014. Of the 9037 patients tested in this window, only those with a wipe coded as the source of their allergen were included in the analysis.
Data were transferred from the original Access format (Access 2010; Microsoft Corp, Redmond, Wash) to Excel (Excel 2010; Microsoft Corp). The Pearson χ2 test was used to analyze differences between the population with an allergy to wipes and those without. When appropriate, Fischer exact test was used. Relative risk and confidence intervals were calculated using SAS software (Statistical Analysis System Version 9.2; SAS Institute Inc, Cary, NC). In total, 17 tests were performed; a Bonferroni-corrected P value of less than 0.003 was used as a cutoff for statistical significance.
There were 9037 patients patch tested by the NACDG during the study period, 79 (0.9%) of whom had an allergic reaction to an allergen coded in a wipe source (Fig. 1). Of these 79 patients, 69 (87.3%) reacted to NACDG allergens only, 4 (5.1%) reacted to both NACDG and non-NACDG allergens, and 6 (7.6%) reacted to non-NACDG allergens only. One patient had both an allergic reaction and irritant dermatitis associated with wipes.
Features of the study population are summarized in Table 1. There were no statistically significant differences in sex, age, race, atopic history, or occupational relatedness of dermatitis in those with an allergy to wipes compared with those without wipe allergy. Only 1 occupational case of allergic contact dermatitis secondary to a wipe was observed. This patient had hand dermatitis, a positive patch test reaction to iodopropynyl butylcarbamate (IPBC), and employment as a punching/stamping press machine operator. Body site of dermatitis was, in general, not associated with wipe allergy with 1 major exception. Patients with wipe allergy were 15 times more likely to have anal/genital dermatitis (P < 0.0001) compared with those without wipe allergy.
Patch Test–Implicated Allergens
More than 92% of wipe-allergic patients had their wipe allergen detected by the NACDG screening series. The NACDG allergens identified in wipes with the highest reaction rates were the following preservatives: MI (59.0%), MCI/MI (35.6%), bronopol (2-bromo-2-nitropropane-1,3-diol, 27.4%), and IPBC (12.3%). Less commonly identified allergens included methyldibromoglutaronitrile/phenoxyethanol, fragrance mix I, Myroxylon pereirae resin, cinnamal, fragrance mix II, quaternium-15, formaldehyde 1.0%, formaldehyde 2.0%, and tocopherol (all ≤ 5.5%, Table 2). Most allergic reactions were of definite or probable clinical relevance.
This study explored the prevalence of wipes as a source of allergens in patients referred for patch testing. There were several key findings. First, wipes as a source of contact dermatitis are fairly uncommon, representing 0.9% of patch-tested patients. Second, the NACDG screening series seems to be a good screening tool for those with suspected wipe allergy, identifying 92.4% of patients. Third, there was a strong and significant association between wipes and anal/genital dermatitis. Lastly, the most common allergen found in wipes was MI, which alone was responsible for 59.0% of allergic reactions.
Although there was no significant difference between the number of adults (age, ≥ 18 years) with a wipe allergy and those without, it is interesting to note that most patients were not pediatric. There were no infants (age, ≤ 1 year) or toddlers (age, 1-3 years); only 3 children (age, 4-17 years) had a positive patch test to an allergen associated with wipes, all of whom had exclusively anogenital dermatitis. There are several possible explanations for the paucity of pediatric wipe-associated contact dermatitis, including the following: relatively small number of pediatric patients tested by the NACDG (4.9% of the population in this database),21 other relevant sources of allergens (eg, moisturizers, cleansers, shampoos), and/or less readily available containers/ingredient lists for wipes during patient visits to confirm source. Alternatively, wipes may not be as important a source of allergens in the pediatric population compared with adults.
The significant association between wipes and anogenital dermatitis (P < 0.0001) suggests that wipes are an important source of groin rashes. Previously, allergic contact dermatitis of the anogenital region had been attributed primarily to topical medicaments,22,23 including dibucaine, benzocaine, and hydrocortisone-17-butyrate.24 This study confirms other reports8,10–12,14,15 that wipes are a relevant source of symptoms in this region.
We were surprised that hand dermatitis was not significantly associated with wipe sources, as reported by Boyapati et al.7 The lack of statistical association may be due to relatively small numbers and/or other more common relevant sources for allergens found in wipes such as hand soap and moisturizers.
Preservatives were responsible for most positive patch test reactions associated with wipes. The top 4 allergens (Table 2) and 8 (61.5%) of 13 total allergens associated were preservatives.
Methylisothiazolinone and MCI have emerged as significant and widespread allergens.18,19,25 They are found in many personal products including shampoos, conditioners, body washes, hand soaps, and wipes.25 In a comprehensive evaluation of baby wipe ingredients, Yu et al26 found that isothiazolinones were infrequent ingredients (6.3%). This finding, paired with the numerous reports of allergic contact dermatitis due to isothiazolinone-containing wipes,6–8,14–17 underscore the point that although many wipes do not contain isothiazolinones, when present, these are a likely source of sensitization.
In European studies, allergic contact dermatitis secondary to MCI/MI has been characterized as an epidemic.27 In North America, reactions to MCI/MI on patch testing significantly increased from 2010 to 201219 and from 2012 to 2014.18 Recently, American studies have revealed the discordance in allergen detection when testing patients to MCI/MI versus MI alone.28 This discrepancy led to the addition of MI to the NACDG screening series in 2013. In this study, more than half of patients with MI sensitivity would have been missed if only MCI/MI had been tested (data not shown).
Bronopol (2-bromo-2-nitropropane-1,3-diol) is a preservative found in cosmetics, topical medications, shampoos, soaps, and wipes.29 According to the most recent NACDG data report, the allergic reaction rate to bronopol in North America was 2.1%.18 Compared with the general patch test population, the reaction rate to bronopol in those with an allergy to a wipe source was considerably higher (27.4%). Fields et al10 described sensitivity to bronopol, confirmed with a positive use test to a wipe containing bronopol, in a 62-year-old woman. Bronopol sensitivity can result from the molecule itself or from formaldehyde, which is released as the compound degrades.29 Formaldehyde (1.0% and 2.0%) and another formaldehyde releaser (quaternium-15) were uncommon allergens associated with a wipe source in our study. In the review of potential allergens in 63 diaper wipes by Yu et al,26 14.3% of wipes contained formaldehyde releasers, most commonly dimethylol dimethyl (DMDM) hydantoin. We found no cases of wipe allergy attributed to DMDM hydantoin in our database.
There are also reports of patch test reactions to IPBC found in wipes.9–11 As a small lipophilic molecule, IPBC can easily penetrate the skin, contributing to its allergenicity.30 Recent reports estimate the reaction rate of IPBC in the patch test population to be 4.7%,18 but among those with an allergy to a wipe source, IPBC was responsible for 12.3% of positive patch test reactions. Iodopropynyl butylcarbamate is a preservative that was originally used in wood and paints, but its prevalence in cosmetic products has been increasing.29 Warshaw et al31 analyzed IPBC patch test reactions and identified personal care products, a category that would have included wipes during the period of that study, as the most common source of this allergen.
Fragrance and fragrance-related allergens represented 12.3% of positive patch test reactions to allergens found in wipes. Fragrances are commonly added to personal care products, including wipes. Although fragrances represent 2 of the top 10 allergens in the NACDG database,18 our data suggest that they are less commonly an issue in wipes as compared with preservatives.
The NACDG screening series identified a significant proportion (92.4%) of patients with an allergy to an ingredient in wipes; however, an additional 10 patients had an allergen identified in a wipe that would have been missed without supplemental testing. Auxiliary testing is important to consider in patients presenting with symptoms suspicious for wipe allergy, especially if a different screening series is used. For example, thin-layer rapid use epicutaneous patch test (T.R.U.E. TEST®) does not contain the most common wipe allergen MI (alone or at a significantly greater concentration than that present in MCI/MI), IPBC, many isolated fragrances, or tocopherol. Many patients with wipe allergy could be missed if only screened with this method. The American Contact Dermatitis Society (ACDS) Core Allergen Series contains all of the NACDG identified wipe allergens.32
There are several limitations associated with this study. First, as a cross-sectional study, causative relationships cannot be established. Second, only a single source was recorded for each allergen. In the event that an allergen was present in multiple products, only the source that was most likely to be clinically correlated with the patient's symptoms was recorded. This likely resulted in underreporting of allergens identified in wipe sources. Third, the name of a non-NACDG allergen identified in a wipe is not recorded. Finally, the study population included in the NACDG database is a tertiary referral population that is not representative of the general population or the average dermatology population.
The prevalence of allergic contact dermatitis associated with an allergen in a wipe source from 2011 to 2014 in North America was 0.9%. Anal/genital dermatitis was strikingly higher among those with a wipe-associated allergy, although it is important to realize that wipes are marketed specifically for use on the face and hands as well. Methylisothiazolinone was the most common clinically correlated allergen in wipes. Other preservatives, including MCI, bronopol (2-bromo-2-nitropropane-1,3-diol), and IPBC, were also problematic allergens. Further investigation into the prevalence of these compounds in wipes will help characterize their potential to induce allergic contact dermatitis in patients using wipes.
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