Dispositivos médicos en pacientes diabéticos y dermatitis de contacto / Medical Devices in Patients With Diabetes and Contact Dermatitis

El desarrollo y comercialización de los sensores de glucosa y las bombas de insulina han supuesto una revolución en el control de los pacientes diabéticos. En los últimos años se han detectado múltiples casos de dermatitis de contacto relacionados con estos dispositivos médicos, con el creciente interés sobre los alérgenos responsables de la sensibilización. Isobornil acrilato fue sin duda el alérgeno principal del dispositivo FreeStyle, motivando al fabricante a modificar la composición eliminando este alérgeno. Curiosamente, este alérgeno está presente en casi todos los sensores comercializados. La colofonia y derivados del ácido abiético desempeñan un papel relevante en cuanto al adhesivo. Recientemente aparecen nuevos componentes identificados como alérgenos, no comercializadas, como el dipropilene glicol diacrilato, la N,N-dimetilacrilamida, o el metacrilato de trietilenglicol, que están siendo foco de estudio. El impacto positivo que tiene el uso de estos dispositivos puede verse mermado por la sensibilización a uno de sus ingredientes, obligando en ocasiones a abandonar el dispositivo, y por ende, restando calidad de vida. El dermatólogo debe posicionarse respecto al estudio dirigido de estos pacientes, dando soporte a los servicios de endocrinología, con la finalidad de orientar tanto el cuidado de la piel como las alternativas posibles, especialmente con la colaboración de los fabricantes.(AU)

The development and commercialization of glucose sensors and insulin pumps has revolutionized the management of diabetes. These devices have been linked to multiple cases of contact dermatitis in recent years, however, giving rise to a growing interest in identifying the sensitizing allergens. Isobornyl acrylate was clearly identified as one of the main allergens responsible for contact dermatitis among users of the FreeStyle glucose sensor and was subsequently removed from the product ingredients. Remarkably, however, it is still used in most other sensors on the market. The common adhesive ingredients colophony and abietic acid derivatives have also been shown to be sensitizing agents. New components under study, such as dipropylene glycol diacrylate, N,N-dimethylacrylamide, and triethylene glycol methacrylate have recently been identified as allergens, though they are not commercially available for clinical testing. The benefits offered by glucose sensors and insulin pumps may be offset by sensitization to product ingredients, in some cases forcing discontinuation and diminishing quality of life. Dermatologists should play a role in this clinical and research scenario, offering case-by-case guidance to endocrinologists on skin care and possible alternatives for patients with glucose sensors and insulin pumps who develop contact dermatitis. They should also collaborate with the manufacturers developing these devices.(AU)

[Translated article] Medical Devices in Patients With Diabetes and Contact Dermatitis / Dispositivos médicos en pacientes diabéticos y dermatitis de contacto

El desarrollo y comercialización de los sensores de glucosa y las bombas de insulina han supuesto una revolución en el control de los pacientes diabéticos. En los últimos años se han detectado múltiples casos de dermatitis de contacto relacionados con estos dispositivos médicos, con el creciente interés sobre los alérgenos responsables de la sensibilización. Isobornil acrilato fue sin duda el alérgeno principal del dispositivo FreeStyle, motivando al fabricante a modificar la composición eliminando este alérgeno. Curiosamente, este alérgeno está presente en casi todos los sensores comercializados. La colofonia y derivados del ácido abiético desempeñan un papel relevante en cuanto al adhesivo. Recientemente aparecen nuevos componentes identificados como alérgenos, no comercializadas, como el dipropilene glicol diacrilato, la N,N-dimetilacrilamida, o el metacrilato de trietilenglicol, que están siendo foco de estudio. El impacto positivo que tiene el uso de estos dispositivos puede verse mermado por la sensibilización a uno de sus ingredientes, obligando en ocasiones a abandonar el dispositivo, y por ende, restando calidad de vida. El dermatólogo debe posicionarse respecto al estudio dirigido de estos pacientes, dando soporte a los servicios de endocrinología, con la finalidad de orientar tanto el cuidado de la piel como las alternativas posibles, especialmente con la colaboración de los fabricantes.(AU)

The development and commercialization of glucose sensors and insulin pumps has revolutionized the management of diabetes. These devices have been linked to multiple cases of contact dermatitis in recent years, however, giving rise to a growing interest in identifying the sensitizing allergens. Isobornyl acrylate was clearly identified as one of the main allergens responsible for contact dermatitis among users of the FreeStyle glucose sensor and was subsequently removed from the product ingredients. Remarkably, however, it is still used in most other sensors on the market. The common adhesive ingredients colophony and abietic acid derivatives have also been shown to be sensitizing agents. New components under study, such as dipropylene glycol diacrylate, N,N-dimethylacrylamide, and triethylene glycol methacrylate have recently been identified as allergens, though they are not commercially available for clinical testing. The benefits offered by glucose sensors and insulin pumps may be offset by sensitization to product ingredients, in some cases forcing discontinuation and diminishing quality of life. Dermatologists should play a role in this clinical and research scenario, offering case-by-case guidance to endocrinologists on skin care and possible alternatives for patients with glucose sensors and insulin pumps who develop contact dermatitis. They should also collaborate with the manufacturers developing these devices.(AU)

Use of guinea pig data to obtain starting points for skin sensitisation risk assessment - A commentary.

The increasing drive to understand the likelihood of skin sensitisation from plant protection products (PPPs) in workers and the general public has resulted in recent initiatives to establish a quantitative risk assessment (QRA) methodology applicable to these products and their exposure scenarios. The effective evaluation of skin sensitising substances requires not only the identification of that toxicological hazard, but also determination of relative sensitising potency. Typically, this has been achieved by interpretation of local lymph node assay (LLNA) dose response data, delivering what is known as the EC3 value. This permitted regulatory division of skin sensitisers into defined potency sub-categories, but more importantly enabled derivation of a no expected sensitisation induction level (NESIL) as the point of departure for QRA. However, for many existing substances there is no LLNA data, only older guinea pig results exist. To avoid additional (in vivo) testing, an approach has been outlined to employ guinea pig data and existing regulatory guidelines on the determination of potency sub-categorisation to provide a guinea pig based NESIL. The approach adopts a conservative extrapolation from LLNA NESIL benchmarks to deliver points of departure as the basis for the type of QRA process already in successful use by other industries.

Increasing non-cosmetic exposure and sensitization to isothiazolinones require action for prevention: Review.

Frequent use of methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) and MI in cosmetic products has been the main cause of widespread sensitization and allergic contact dermatitis to these preservatives (biocides). Their use in non-cosmetic products is also an important source of sensitization. Less is known about sensitization rates and use of benzisothiazolinone (BIT), octylisothiazolinone (OIT), and dichlorooctylisothiazolinone (DCOIT), which have never been permitted in cosmetic products in Europe. BIT and OIT have occasionally been routinely patch-tested. These preservatives are often used together in chemical products and articles. In this study, we review the occurrence of contact allergy to MI, BIT, OIT, and DCOIT over time, based on concomitant patch testing in large studies, and case reports. We review EU legislations, and we discuss the role of industry, regulators, and dermatology in prevention of sensitization and protection of health. The frequency of contact allergy to MI, BIT, and OIT has increased. The frequency of contact allergy to DCOIT is not known because it has seldom been patch-tested. Label information on isothiazolinones in chemical products and articles, irrespective of concentration, is required for assessment of relevance, information to patients, and avoidance of exposure and allergic contact dermatitis.

Assessing the efficacy of a German-inspired intervention on occupational contact dermatitis in Denmark: A randomised controlled trial with 3-month follow-up.

BACKGROUND: Occupational contact dermatitis (OCD) is a prevalent, often chronic disease that poses a risk for job loss and decreased quality of life. In Germany, a multi-step prevention programme emphasising early detection and highly specialised multidisciplinary treatment has been implemented with great success. OBJECTIVES: To examine the effectiveness of a Danish-adapted version of the German prevention effort on OCD severity, quality of life and occupational consequences at 3-month follow-up. METHODS: Randomised, controlled trial. Participants were recruited after the first referral from General Practitioner to Dermatologist with suspected OCD. The intervention group (IG) received a Danish-adapted, multidisciplinary intervention, while the control group (CG) navigated the Danish healthcare system without interference from the study. OCD severity, occupational consequences and quality of life were assessed at 3-month follow-up using self-reported questionnaires. RESULTS: A statistically significant decrease in the severity of eczema was found at 3-month follow-up in the IG compared to the CG. The IG were statistically significantly more likely to have seen a dermatologist at 3-month follow-up. Higher treatment level in the IG was indicated by the results but was not statistically significant. No significant difference was found in quality of life or occupational consequences. CONCLUSIONS: These initial findings suggest that early and specialised treatment of OCD improves OCD prognosis.

Acrylates in artificial nails-Results of product analyses and glove penetration studies.

BACKGROUND: Artificial nail materials are mixtures that are prone to contain several sensitizing (meth)acrylates. It is not known whether the listing of (meth)acrylates is correct in these products' packages. Protective gloves suited for nail work are needed. OBJECTIVES: To analyse (meth)acrylates in gel nail and acrylic nail products chemically and to compare the results with the information in the product labels, and to study penetration of artificial nail materials through selected disposable gloves. METHODS: We analysed 31 gel nail products and 6 acrylic nail products for their (meth)acrylate content by gas chromatography-mass spectrometry (GC-MS). We tested the penetration of two nail products through three disposable gloves: nitrile rubber, neoprene rubber and polyvinyl chloride (PVC). RESULTS: Altogether 32/37 products contained (meth)acrylates. In all of them, there was discrepancy between the listed (meth)acrylates and those discovered in the analysis. The commonest (meth)acrylates were hydroxyethyl methacrylate (HEMA, 20/37 samples) and hydroxypropyl methacrylate (HPMA, 9/37 samples), but many of the product packages failed to declare them. Isobornyl acrylate (IBA) was discovered in nine gel nail products. The neoprene glove could withstand nail gel for 20 min and thin nitrile glove and PVC glove for 5 min. Acrylic nail liquid penetrated through disposable gloves quickly. CONCLUSIONS: Labelling of artificial nail products was notably incorrect on most products. Requirements for product labelling must be updated so that the risk of sensitization associated with artificial nail products is clearly indicated. Disposable gloves can probably be used short-term in gel nail work, whereas disposable gloves do not protect the user from acrylic nail liquids.

Dermato-allergological risks in beauty operators.

Beauticians, hairdressers, and barbers are among the occupations with the highest rates of work-related skin diseases, especially occupational contact dermatitis (OCD). Irritant contact dermatitis (ICD) due to chronic mild trauma (frictional dermatitis), contact with soaps, detergents, and wet work is frequent in beauty operators. Para-phenylenediamine (PPD), acrylates, essential oils, fragrances, colophony, and preservatives are most frequently responsible for allergic contact dermatitis (ACD) in these professional categories. Young women are mainly affected, with the most affected sites being the hands. Anamnesis, patch tests with the baseline, integrative series, and use products are important to understand possible sensitization. To reduce the risk, prevention is important, and workers should be adequately trained in the use of personal protective equipment (PPE).

Assessing the risk of induction of skin sensitization to plant protection products: A quantitative approach.

Exposure to skin sensitizers is common and regulated in many industry sectors. For cosmetics, a risk-based approach has been implemented, focused on preventing the induction of sensitization. First, a No Expected Sensitization Induction Level (NESIL) is derived, then modified by Sensitization Assessment Factors (SAFs) to derive an Acceptable Exposure Level (AEL). The AEL is used in risk assessment, being compared with an estimated exposure dose, specific to the exposure scenario. Since in Europe there is increased concern regarding exposure towards potentially sensitizing pesticides via spray drift, we explore how existing practice can be modified to allow Quantitative Risk Assessment (QRA) of pesticides for bystanders and residents. NESIL derivation by the Local Lymph Node Assay (LLNA), the globally required in vivo assay for this endpoint, is reviewed alongside consideration of appropriate SAFs. Using a case study, the principle that the NESIL in µg/cm2 can be derived by multiplying LLNA EC3% figure by a factor of 250 is adopted. The NESIL is then reduced by an overall SAF of 25 to establish an exposure level below which there is minimal bystander and resident risk. Whilst this paper focuses on European risk assessment and management, the approach is generic and universally applicable.

Diagnostics and Prevention of Occupational Allergy in Hairdressers.

PURPOSE OF REVIEW: This study aims to provide an overview on current knowledge on occupational allergic diseases in hairdressers and up-to-date perspectives of prevention. RECENT FINDINGS: Hand eczema (dermatitis) is common in hairdressers, often caused by contact allergy to one or multiple small molecules (haptens) used, e.g., for dyeing, bleaching, and waving/relaxing or by ancillary substances such as preservatives. Hairdressers, compared to other patch-tested patients, have an up to fivefold increased risk to be found sensitized, e.g., against p-phenylenediamine, ammonium persulfate, and glyceryl thioglycolate. Some of these small molecules may induce respiratory sensitization causing allergic rhinitis and/or asthma, notably persulfate salts. Occupational hazards in hairdressing are well described. This knowledge needs to be put into use for risk reduction, mainly by substitution of allergenic ingredients by less allergenic ones, education, and use of ventilation and suitable single-use gloves.

Risk management of skin sensitisers: A commentary.

Historically, allergic contact dermatitis (ACD) to chemicals encouraged hazard identification improvements, more sophisticated risk assessment and implementation of regulatory strategies, including banning of specific sensitising substances. The validation process applied to hazard identification methods demonstrates their accuracy; their use to characterise sensitiser potency facilitates quantitative and transparent risk assessment. Diagnostic patch testing at dermatology clinics worldwide delivers feedback showing where risk assessment/management has been insufficient or did not target the exposure of concern, thereby facilitating improvements. When urgent action to protect human health was required, regulations limited/banned, specific skin sensitisers. This can be seen in practice with the fragrance industry, a known source of ACD, thus requiring risk management, usually restrictions to limit allergy induction, and very rarely specific bans on ingredients. Experience and development of more sophisticated tools, e.g. to assess aggregate exposure from multitude of consumer product types, has led to repeated adaptation of risk assessment and promulgation of updated fragrance use limits. Although targeted control may not always lead to rapid change in the overall clinical picture, it is preferable to a blanket undifferentiated regulatory control of all sensitisers, resulting in unwarranted restrictions for many uses of no health concern, with consequent substantial socio-economic impacts.

Sunscreens: A Review of UV Filters and Their Allergic Potential.

Abstract Active ingredients of sunscreens, or UV filters, have increased in use because public awareness of sun safety has risen. In addition to this intentional use, unintentional exposures to UV filters also occur through application of personal care products, where the filters are incorporated into the product. There are 2 main types of UV filters: organic (chemical) filters and the 2 inorganic (mineral) filters, titanium dioxide and zinc oxide. Both allergic contact dermatitis (ACD) and photoallergic contact dermatitis (PACD) have been caused by organic filters; oxybenzone (benzophenone-3) is the most frequently reported contact and photocontact allergen compared with all other UV filters. There are no reports of ACD or PACD to the inorganic (physical) UV filters. Here, we review the categories of sunscreens available, currently marketed UV filters, and their corresponding ACD and PACD.

Tackling Acrylate Allergy: The Sticky Truth.

Acrylates are synthetic thermoplastic resins used in numerous industries since their discovery in the mid-19th century. Known for their versatility in formulating various consumer, health care, and industrial products, acrylates also have come under scrutiny for their potential to cause allergic contact dermatitis (ACD). Allergic contact dermatitis to acrylates previously was largely occupational in nature, but the expanded use of acrylates in products ranging from nail cosmetics to medical devices has increasingly brought this allergy to the general population. Herein, we discuss the chemistry and allergenicity of acrylates and highlight common sources of exposure, clinical presentations, pertinent considerations for patch testing, and tips for the management/prevention of acrylate ACD. We hope to emphasize the shifting trend of exposure sources from the workplace to consumers, underlining the need for increased vigilance from physicians. Collaborative efforts among health care providers and patient education about allergen avoidance strategies are essential to mitigate potential complications arising from acrylate sensitization.

Development of a new hydrogel for the prevention of allergic contact dermatitis.

Allergic contact dermatitis (ACD) is the most prevalent occupational disease and the most common form of immunotoxicity in humans. Preventing exposure to the triggering allergens is the mainstay of treatment. However, avoidance is not always possible in an occupational setting. From a pathophysiological point of view, a variety of events are involved in the development of ACD, including the formation of immunogenic complexes following the stable association of the allergen with skin proteins, which is thought to be the molecular initiating event responsible for the development of ACD. Previously, the team identified molecules that exhibited higher antiallergic potential due to their capacity to block the interaction between allergens and skin proteins. These assumptions were the starting point for the design of this work aiming to develop and characterize a new hydrogel containing the active ingredients lysine and N-acetyl cysteine under the premises of quality- and safety- by design. Two factorial plannings were established envisioning the optimization of the hydrogel in terms of mechanical and rheological properties. In vitro release and permeation studies supported its skin surface barrier effect. In addition, the selected hydrogel proved to be safe without causing human skin irritation or skin sensitization.

Nail Salon Safety: From Nail Dystrophy to Acrylate Contact Allergies.

Nail cosmetics are an integral practice in many patients' lives. However, the manicuring process can result in nail damage via instrumentation, allergens in nail polish, and infections. Many of these nail disorders are preventable through proper education. Therefore, it is critical for physicians to understand the steps involved in regular, gel, and acrylic manicures and educate patients on how to protect their natural nails. Simple preventative measures can be discussed with patients and make a substantial difference in their long-term nail health.

Quantitative risk assessment of allergens leaching from menstrual hygiene products.

Allergic contact dermatitis (ACD) often associated with the topical use of perfumed products, remains one of the most common chronic skin disorders in Western countries. Since labelling of scented menstrual hygiene products (MHPs) is not mandatory, women might be unknowingly exposed to allergens. Given that vaginal mucosae lack the vital barrier function of the skin, skin allergens can easily penetrate and become systemically available and hence women may experience adverse effects in the anogenital region. The aim of this study was therefore to investigate whether women using scented MHPs are at risk of sensitization and hence developing ACD. Hereto, a Quantitative Risk Assessment (QRA) is performed on four well-known skin sensitizing chemicals (α-isomethyl ionone, benzyl salicylate, hexyl cinnamaldehyde and heliotropine) that were previously found leaching from five different scented MHPs including tampons and sanitary pads. The amounts of heliotropine, leached by one of the investigated tampons, exceeded acceptable exposure levels determined with the QRA and could induce sensitization. In addition, although no sensitization is expected for the other three compounds, an allergenic reaction might be provoked in women who are already sensitized. Labelling of allergens on scented MHPs would therefore help consumers to prevent adverse effects linked to ACD.

Preservatives in non-cosmetic products: Increasing human exposure requires action for protection of health.

The widespread use of skin sensitizing preservatives is well-known. Contact allergy to preservatives is often caused by their presence in cosmetic products. Preservative use in non-cosmetic products is less well-known. We have reviewed European Union (EU) legislations on classification and labelling, biocides and cosmetics, concerning conditions for use of the most used sensitizing preservatives (including formaldehyde-releasing substances, isothiazolinones and parabens). We have analysed temporal trends in their use in non-cosmetic products (tonnes, number of products, concentrations), based on annual reports to the Swedish Products Register 1995-2018; and we discuss implications for stakeholders. Major changes over time are that the use of most of the preservatives has increased by tonnes and/or by number of products, and that several use concentrations have declined following harmonized classification as a skin sensitizer with low concentration limits for this classification. We conclude that the massive increase in use of preservatives is alarming, and that urgent action is needed for protection of health. Their use in non-cosmetic products is broad, increasing and often undisclosed. In the EU, legislations concerning chemicals can provide relevant restrictions to reduce their use and associated health risks, monitored by efficient surveillance. Prevention would be benefited by better coordination between legislations.

A clinical evaluation of a permanent hair dye designed to reduce allergic contact dermatitis and hair damage.

BACKGROUND: Permanent hair dye is the most commonly used anti-aging procedure used by both men and women. However, permanent hair dye can cause irritant contact dermatitis due to ammonia and allergic contact dermatitis due to paraphylenediamine (PPD). METHODS: This research examined an ammonia-free and PPD-free permanent hair dye in 50 ethnically diverse females 21-91 years of age who were current users of permanent hair dyes. Subjects were patch tested prior to dyeing. Two dye sessions were undertaken at baseline and 2-6 weeks post-baseline depending on the dyeing habits of the subject. RESULTS: 50/50 subjects successfully completed the study with no incidence of allergic or irritant contact dermatitis. After 2 dyeing procedures, the dermatologists rated an 87% improvement in hair shine, 90% improvement in hair color, 88% improvement in hair moisturization, 87% improvement in hair porosity, and 88% improvement in hair combability. CONCLUSIONS: A MEA-based ammonia-free cream hair color without PPD or resorcinol was safe for use on the hair and scalp of females with diverse hair types and textures.