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Background There is considerable variability across European patch test centres as to which allergens are included in local and national cosmetics series. Objectives To propose a standardised, evidence-based cosmetic series for Europe based on up-to-date analysis of relevant contact allergens. Methods We collated data from the European Surveillance System on Contact Allergies (ESSCA) from 2009-2018 to determine which cosmetic allergens produce a high yield of contact allergy. Contact allergens with a prevalence of >0.3% that were considered relevant were included. Rare contact allergens were excluded if deemed no longer relevant or added to a supplemental cosmetic series for further analysis. Results Sensitisation prevalence rates of 39 cosmetic contact allergens are tabulated. Thirty of these allergens yield >0.3% positive reactions and are therefore included in our proposed European Cosmetic Series. Six are considered no longer relevant and therefore excluded. Three are included in a supplementary European cosmetic series. An additional 9 allergens are included in either the core or supplemental European cosmetic series following literature review. Conclusion We have derived a potential European cosmetic series based upon the above methods. This will require ongoing investigation based upon the changing exposure profiles of cosmetic allergens as well as new and evolving substances. This article is protected by copyright. All rights reserved.

BACKGROUND Changing patterns of exposure lead to changes in the spectrum of contact allergy in the general population and in patients patch tested for suspected contact allergy. The main contact allergens (haptens) are assembled in the so-called 'baseline series'. OBJECTIVES To present the current spectrum of contact allergy to baseline series allergens, and its temporal development over the last 12 years, based on data collected by the 56 active departments of the trinational Information Network of Departments of Dermatology (IVDK). METHODS Patch-test data, along with core demographic and clinical information, subdivided into 4-year periods for all patients patch tested with the baseline series in the IVDK, were analysed descriptively. Moreover, log-binomial regression analysis addressed temporal trends of specific contact allergies, adjusted for potentially confounding factors. RESULTS Among the 125 436 patients tested with the German baseline series, the most common allergens were nickel (14·7%), fragrance mix I (8·1%), Myroxylon pereirae resin (7·5%) and cobalt (5·2%), with no conclusive trend. The rise and fall of contact allergy to methylchloroisothiazolinone/methylisothiazolinone (MI), following (self-) regulation in the European Union, reflected the MI contact allergy epidemic. Propolis showed a marked upward trend with a prevalence of 3·94% during the period 2015-2018. CONCLUSIONS Decreases in sensitization prevalence likely reflect reduced exposure, with some lag, as seen with hydroxyisohexyl 3-cyclohexene carboxaldehyde. If no (sufficient) decrease can be observed despite interventions, such as for nickel and chromium, affected subgroups should be identified and their causative exposures explored. Finally, increases such as that observed with propolis, certainly warrant targeted investigation of the exposures driving sensitization, and possibly intervention. What is already known about this topic? Contact allergy is prevalent in the general population. Surveillance based on clinical data offers timely information on trends concerning certain allergens or subgroups at risk. What does this study add? This analysis provides an update of the current contact allergy prevalence in Central Europe, including time trends. This study describes the demographic and clinical profile of patients tested from 2007 to 2018. This research identifies contact allergens that require (further) preventive efforts. Linked Comment: Schuttelaar. Br J Dermatol 2020; 183:800-801.

Background The contact allergy prevalences in patch-tested patients are usually higher than those in the population, owing to morbidity-driven selection. Objectives To examine the differences between two samples, one from the population, one from the patch test clinic, in one area of Germany (Jena, Thuringia). Methods Between August 2008 and October 2011, a total of 519 participants of the population-based european dermato-epidemiology network (EDEN) fragrance study were patch tested in Jena using a TRUE Test baseline series extended with some pet.-based (fragrance) allergen preparations. Between 2007 and 2012 (inclusive), 1906 routine patients were patch tested for suspected allergic contact dermatitis (ACD) in the Jena University Hospital Department; of these 1694 (83.2%) with the German baseline series using pet./aq.-based, investigator-loaded allergens. Results In the population (clinical) sample, 19.6% (41.1%) were sensitized to at least one of the allergens considered. The most common baseline series allergens in the population/clinical sample were nickel (10.5%/13.2%), fragrance mix (FM) II (2.9%/6.7%), FM I (2.3%/8.3%), and cobalt (1.6%/5%). The clinical sample was slightly older (71.5% vs 55.9% age 40+) and included less males (36% vs 49.3%). Conclusions Results are quite similar, although prevalences are usually higher in the clinical setting, with the exception of p-tert-butylphenol formaldehyde resin.

Kontaktsensibilisierungen sind nicht selten, und das Spektrum der wichtigsten Allergene kann sich im Lauf der Zeit durch geanderte Expositionen verschieben. Unter Einsatz der kontinuierlich angepassten sog. Standardreihe der wichtigsten Kontaktallergene wurden sowohl bevolkerungsbezogene als auch klinisch epidemiologische Studien durchgefuhrt. Es erfolgt eine einfuhrende Darstellung der wichtigsten epidemiologischen Grundbegriffe sowie spezieller Aspekte in der Epidemiologie der Kontaktsensibilisierung. Eine Aufbereitung von Handbuchwissen und eine selektive Literaturrecherche wurden vorgenommen. Auf Bevolkerungsebene weisen ca. 25 % mindestens eine Kontaktsensibilisierung gegen Substanzen der Standardreihe auf, weit uberwiegend gegen Nickel. Duftstoffe stellen mit einer Pravalenz von ca. 4 % ebenfalls wichtige Allergene dar, zusammen mit Konservierungsmitteln. Bei wegen Verdacht auf ein allergisches Kontaktekzem epikutan getesteten Patienten ist die Rangfolge dieser wichtigsten Allergengruppen ahnlich, jedoch sind die Pravalenzen in der Regel (deutlich) hoher. Kurzfristige Veranderungen der Exposition und nachfolgend des Spektrums der wichtigsten Kontaktallergene lassen sich am besten durch klinische Surveillance auf der Basis von Routinedaten darstellen und ggf. praventive Masnahmen anstosen. Neben der Analyse von Zeittrends spielt die Auswertung bestimmter Subgruppen eine wichtige Rolle bei der Identifikation allergieauslosender (sensibilisierender und elizitierender) Expositionen.

Der diagnostische Standard zum Nachweis einer bestehenden allergischen Kontaktdermatitis ist der Epikutantest. Die vorliegende Leitlinie richtet sich an Assistenz- und Facharzte der Dermatologie, Allergologie und Arzte weiterer Fachgruppen in Klinik und Praxis, die an der Indikationsstellung oder Durchfuhrung von Epikutantests bei Patienten mit Kontaktekzemen und weiteren Spattypallergien beteiligt sind, sowie Kooperationspartner der Arzteschaft (Fachberufe im Gesundheitswesen, Kostentrager). Die Leitlinie zur Durchfuhrung des Epikutantests mit Kontaktallergenen wurde auf der Basis einer systematischen Literatursuche zu definierten Schlusselfragen evidenzbasiert und im formellen Konsensusverfahren (S3) von Dermatologen unter Einbindung von Padiatern, Arbeitsmedizinern, Assistenzpersonal und Patientenvertretern erstellt. Bezuglich der methodischen und inhaltlichen Arbeit, auf denen die Empfehlungen basieren, wird auf Methodenbericht und Evidenztabellen verwiesen. Die Leitlinie stellt allgemeine Aspekte der Epikutantestung sowie medizinrechtliche Aspekte dar. Es werden Empfehlungen gegeben zur Indikationsstellung, Patientenaufklarung, Auswahl von Testsubstanzen und Kammersystemen, Expositionsort, -dauer und Ablesezeitpunkten, Interpretation von Testreaktionen, endogenen und exogenen Einflussfaktoren, Testung besonderer Personengruppen (Kinder, Schwangere, Immunsupprimierte) sowie Risiken und unerwunschten Nebenwirkungen bei der Durchfuhrung des Epikutantests mit Kontaktallergenen.

Epicutaneous patch testing is the diagnostic standard for the detection of allergic contact dermatitis. The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology and allergology as well as other medical specialties involved in establishing the indication for patch testing and its execution in patients with contact dermatitis and other forms of delayed-type hypersensitivity. The target audience also includes other health care providers and insurance funds. Based on a systematic literature search and a formal consensus process (S3), the guidelines were developed by dermatologists in collaboration with pediatricians, occupational medicine physicians, nursing staff as well as patient representatives. The systematic methodological approach and appraisal of evidence upon which the recommendations are based are outlined in a separate method report that also contains evidence tables. The guidelines address general aspects of patch testing as well as medicolegal issues. The recommendations given relate to topics such as the indication for patch testing, informed patient consent, as well as the choice of test substances, test chambers and test site, duration of exposure, reading times and interpretation of test reactions. Furthermore, recommendations are provided with respect to endogenous and exogenous factors, specific patient groups (children, pregnant women, immunosuppressed individuals) as well as possible risks and adverse events associated with patch testing using contact allergens.

Epicutaneous patch testing is the diagnostic standard for the detection of allergic contact dermatitis. The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology and allergology as well as other medical specialties involved in establishing the indication for patch testing and its execution in patients with contact dermatitis and other forms of delayed-type hypersensitivity. The target audience also includes other health care providers and insurance funds. Based on a systematic literature search and a formal consensus process (S3), the guidelines were developed by dermatologists in collaboration with pediatricians, occupational medicine physicians, nursing staff as well as patient representatives. The systematic methodological approach and appraisal of evidence upon which the recommendations are based are outlined in a separate method report that also contains evidence tables. The guidelines address general aspects of patch testing as well as medicolegal issues. The recommendations given relate to topics such as the indication for patch testing, informed patient consent, as well as the choice of test substances, test chambers and test site, duration of exposure, reading times and interpretation of test reactions. Furthermore, recommendations are provided with respect to endogenous and exogenous factors, specific patient groups (children, pregnant women, immunosuppressed individuals) as well as possible risks and adverse events associated with patch testing using contact allergens. Note: This publication is part 1 of the short version of the S3 guidelines for "Epicutaneous patch testing using contact allergens and drugs" (registry no. 013 - 018; date: March 20, 2019; valid until December 31, 2021). Part 2 of the short version will be published in the next issue. The long version of these guidelines can be accessed at www.awmf.org. The method report is available as online publication (https://www.awmf.org/leitlinien/detail/ll/013-018.html) and contains the evidence tables in its appendix.

Der diagnostische Standard zum Nachweis einer bestehenden allergischen Kontaktdermatitis ist der Epikutantest. Die vorliegende Leitlinie richtet sich an Assistenz- und Facharzte der Dermatologie, Allergologie und Arzte weiterer Fachgruppen in Klinik und Praxis, die an der Indikationsstellung oder Durchfuhrung von Epikutantests bei Patienten mit Kontaktekzemen und weiteren Spattypallergien beteiligt sind, sowie Kooperationspartner der Arzteschaft (Fachberufe im Gesundheitswesen, Kostentrager). Die Leitlinie zur Durchfuhrung des Epikutantests mit Kontaktallergenen wurde auf der Basis einer systematischen Literatursuche zu definierten Schlusselfragen evidenzbasiert und im formellen Konsensusverfahren (S3) von Dermatologen unter Einbindung von Padiatern, Arbeitsmedizinern, Assistenzpersonal und Patientenvertretern erstellt. Bezuglich der methodischen und inhaltlichen Arbeit, auf denen die Empfehlungen basieren, wird auf Methodenbericht und Evidenztabellen verwiesen. Die Leitlinie stellt allgemeine Aspekte der Epikutantestung sowie medizinrechtlicher Aspekte dar. Es werden Empfehlungen gegeben zur Indikationsstellung, Patientenaufklarung, Auswahl von Testsubstanzen und Kammersystemen, Expositionsort, -dauer und Ablesezeitpunkten, Interpretation von Testreaktionen, endogenen und exogenen Einflussfaktoren, Testung besonderer Personengruppen (Kinder, Schwangere, Immunsupprimierte) sowie Risiken und unerwunschten Nebenwirkungen bei der Durchfuhrung des Epikutantests mit Kontaktallergenen.

BACKGROUND Studies suggest that patch testing with formaldehyde releasers (FRs) gives significant additional information to formaldehyde 1% aq. and should be considered for addition to the European baseline series (EBS). It is not known if this is also true for formaldehyde 2% aq. OBJECTIVES To determine the frequency of sensitization to formaldehyde 2% aq. and co-reactivity with FRs. To establish whether there is justification for including FRs in the EBS. MATERIALS AND METHODS A 4-year, multi-center retrospective analysis of patients with positive patch test reactions to formaldehyde 2% aq. and five FRs. RESULTS A maximum of 15 067 patients were tested to formaldehyde 2% aq. and at least one FR. The percentage of isolated reactions to FR, without co-reactivity to, formaldehyde 2% aq. for each FR were: 46.8% for quarternium-15 1% pet.; 67.4% imidazolidinyl urea 2% pet.; 64% diazolidinyl urea 2% pet.; 83.3% 1,3-dimethylol-5, 5-dimethyl hydantoin (DMDM) hydantoin 2% pet. and 96.3% 2-bromo-2-nitropropane-1,3-diol 0.5% pet. This demonstrates that co-reactivity varies between FRs and formaldehyde, from being virtually non-existent in 2-bromo-2-nitropropane-1,3-diol 0.5% pet. (Cohen's kappa: 0, 95% confidence interval [CI] -0.02 to 0.02)], to only weak concordance for quaternium-15 [Cohen's kappa: 0.22, 95%CI 0.16 to 0.28)], where Cohen's kappa value of 1 would indicate full concordance. CONCLUSIONS Formaldehyde 2% aq. is an inadequate screen for contact allergy to the formaldehyde releasers, which should be considered for inclusion in any series dependant on the frequency of reactions to and relevance of each individual allergen.

(1) Background: Different sources of information are used by the population regarding skin cancer prevention. The pertinent quality of information that can be retrieved via an internet search engine needs assessment, (2) Methods: Four topical searches in common language were entered into Google™. The first 200 “hits” were stored for further use. Eligible websites were evaluated using content-based criteria based on the current German medical guideline “Skin cancer prevention” and employing generic (DISCERN, HONcode) quality criteria. (3) Results: Overlap between the four search results was between 0 and 7 of 200. The completeness of relevant content was scored with a median of 10 points (first quartile (Q1):6, Q3:14) and thus, it was much lower than the theoretical maximum of 43 points. Global quality, with a maximum of 10 points, was 3 in median (Q1:2, Q3:4). Quality and completeness, respectively, were somewhat higher in the higher ranks of search results. The generic quality was moderate. (4) Conclusions: A direct comparison with other sources of information (print, audio-visual, presentation, or personal counselling) is not possible, but important deficits concerning the quality and scope of relevant information on the internet are demonstrated.

Background Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) has been the most reported fragrance chemical for two decades and will be prohibited in cosmetic products from August 2021. Objectives To describe the time trend of HICC contact allergy in European dermatitis patients in 2009-2019, and the added value of testing HICC separately in the baseline series. Methods Data of 124 472 dermatitis patients routinely patch tested with HICC 5% pet. in the baseline series in the ESSCA network (2009 to 2018) and at the Department of Dermatology and Allergy at Herlev-Gentofte Hospital (2009 to 2019) were reviewed. Results Contact allergy to HICC was found in 1.98% of 9 865 patients in Gentofte and 1.62% of 114 607 patients in the ESSCA network. Overall, the prevalence decreased annually with 0.156 percentage points (P = .001) in Gentofte and 0.051 percentage points (P = .0002) in ESSCA. The frequency of missed contact allergy to HICC when testing only with FMII mix was 0.17% (17/9865) and 0.35% (405/114 607) of the whole test population in Gentofte and ESSCA populations, respectively. Conclusions This is the first study to demonstrate a significant decline in HICC allergy in European dermatitis patients, most likely attributed to the upcoming European ban. This article is protected by copyright. All rights reserved.

Background: Long-term data on inflammatory bowel disease (IBD) patients switched from originator to biosimilar infliximab SB2 are lacking. The aim of the conducted study was to investigate the effectiveness, immunogenicity and safety of a large prospectively followed-up IBD patient cohort that was entirely switched from originator infliximab to biosimilar SB2 treatment. Methods: This was a prospective, single-center, longitudinal, observational study describing clinical outcomes in IBD patients, over an 80-week period following switch from originator infliximab to SB2. Primary outcome measures were change of disease activity [Harvey-Bradshaw Index for Crohn’s disease (CD), partial Mayo Score for ulcerative colitis (UC)], C-reactive protein (CRP), infliximab trough levels (TLs), anti-drug antibodies (ADAs) and adverse events. Results: One hundred and forty-four IBD patients (94 CD, 50 UC), with median duration of 30.5 months’ (range 2–110) treatment with originator infliximab were evaluated. Mean change of disease activity compared with baseline was −0.9 (SD 2.6), –0.4 (2.2) and –0.4 (2.0) in CD; 0.1 (1.1), 0.1 (1.1) and 0.1 (1.3) in UC patients at weeks 24, 48 and 72. Median infliximab TLs were 6.2 µg/ml (interquartile range 2.3–12.2), 5.0 µg/ml (2.7–10.0), 6.6 µg/ml (3.5–12.4) and 5.1 µg/ml (2.7–10.9) at baseline and weeks 24, 48 and 72. Median CRP levels were within normal ranges throughout the study. After the switch, 9.8% of the patients developed new ADAs. Persistence on SB2 was 90% (95% confidence interval 0.85–0.95), 79% (0.72–0.86), 72% (0.64–0.80) at weeks 26, 52 and 78. Serious adverse events occurred in 11 patients. Conclusion: Over the individual patient follow-up of 80 weeks, switch to biosimilar SB2 from originator infliximab does not result in increased disease activity or changed immunogenicity patterns. The switch to SB2 was well tolerated.

This chapter summarises all relevant aspects of patch testing, closely following recommendations outlined in a recent European, and a German S3 guideline on diagnostic patch testing with contact allergens and medicinal products (drugs). Patch testing is indicated in patients suspected of suffering, or having been suffering, from delayed-type hypersensitivity leading to allergic contact dermatitis or other skin and mucosal diseases. Sections of this chapter include detailed indications, reasons for possibly postponing the test, considerations on choosing haptens (contact allergens) to test, various aspects of the application of patch test allergen preparations (storage, dosing) and of testing with individual materials provided by the patients. Special aspects of patch testing in cutaneous adverse drug reactions, children, or occupational contact dermatitis are outlined. Supplemental test methods, notably the repeated open application test, are briefly described. Finally, the final evaluation in terms of assessment of clinical relevance of reactions and patient counselling are outlined.

Among the basic protective measures against COVID-19, the need to wash hands frequently and in a prolonged way using soap, and to regularly use alcohol-based hand sanitizers is well established for the whole population. Healthcare workers in general, and particularly those involved in the direct care of COVID-19 patients, have to wear personal protective equipment (PPE) daily for many hours and also accomplish general preventive measurements outside their work. Cutaneous adverse reactions can develop that need to be prevented, identified and therapeutically managed. According to the data reported by Lin et al 1, based in the experience from healthcare workers in Wuhan, adverse skin reactions were reported in 74% of responders (n=376) to a general survey. The most commonly reported types of eruptions were skin dryness or desquamation (68.6%), papules or erythema (60.4%) and maceration (52,9%). (Less)

Background Assessment of the clinical relevance of patch test reactions is an essential part of the diagnostic work-up of patients with (occupational) contact dermatitis. However, final diagnostic information, particularly the clinical relevance of allergic patch test reactions, has hitherto been ill-represented in clinical documentation systems (patch test software) and surveillance registries based on these. Objectives To develop, implement as a pilot study, and analyse concerning feasibility and contents a new concept of representing the full scope of diagnostic information utilized in the diagnosis of patients with (occupational) contact dermatitis. Methods On the basis of a European working group discussion on items to document and catalogue lists to use for this purpose, an online documentation system to collect data was set up, followed by pilot use involving 9 dermatology departments across Europe. Results Data on 176 patients with suspected occupational hand dermatitis were included; among these, work-relatedness was confirmed in 150, and in 53 non-occupational aetiology was the sole or a contributory cause. Data were further analysed with regard to occupations, product categories, substances (haptens), source of information on which the evaluation was based, and various combinations of these factors, to illustrate the usefulness of the proposed data representation. Conclusions An improved method of data collection is presented that more accurately links allergen to exposure and to clinical disease and patient history, and thus better represents clinical relevance. This enables more precise analysis of the causation of contact dermatitis, occupational or non-occupational, and thereby better targeting of prevention. The development of future databases should incorporate the above considerations to record the results of investigation.

Background Risk factors for p-phenylenediamine (PPD) sensitization include the use of hair dyes, the application of temporary black henna tattoos, working as a hairdresser, and, possibly, exposure to hair dye pretests. Objectives To quantify the impact of these (putative) risk factors on PPD sensitization. Methods Six items related to PPD exposure were added to the routine Information Network of Departments of Dermatology questionnaire from 2008 to 2013. A retrospective analysis of data from 4314 patients tested with PPD 1% pet. was conducted. Results Of the PPD-positive patients (n = 271), 80% had their hair dyed, and, of these, 57% subsequently developed scalp dermatitis, whereas only 11% had had a henna tattoo. The self-administrated pretest with hair dye was performed by only a few patients, precluding a more detailed analysis. Hair dyeing [odds ratio (OR) 6.0; 95% confidence interval (CI): 3.9-9.4], henna tattoos (OR 2.4; 95%CI: 1.5-3.7) and being a hairdresser (OR 2.1; 95%CI: 1.3-3.2) increased the risk of PPD sensitization. Neither dyeing of own hair nor application of a temporary henna tattoo seemed to affect PPD sensitization in hairdressers. p-Aminoaryl compounds more often gave positive reactions in patients with henna tattoo. Conclusions Hair dyeing is the major risk factor for PPD sensitization in this clinical setting, and application of a temporary black henna tattoo may also lead to (strong) PPD sensitization.

SummaryBackground In 2011, a multicentre study was conducted in order to determine how hair dye manufacturers instructed consumers to perform a self-test prior to dyeing their hair, in order to identify individuals who are likely to react upon subsequent hair dyeing. A number of concerns were raised concerning the variability in instructions between products and producers, and the safety and validity of this tool. Objectives To perform a 5-year follow-up study in order to determine whether manufacturers still recommend a self-test, and if so, whether the procedures have been changed. Methods During March 2016, a total of 40 oxidative hair dye products from 21 different manufacturers were bought in retail stores in 8 European countries. Results The consumers were instructed to perform a self-test prior to hair dyeing for 39 of the products; however, the procedures varied greatly regarding the method of application, the amount of hair dye applied, the location and size of the application area, the number of applications, whether or not rinsing was performed after application, the reading times, and how a positive reaction was defined. Conclusions Self-testing is still recommended by almost all manufacturers of permanent hair dyes. There are major variations in the instructions, even in products from the same manufacturer. The previously raised concerns regarding safety and validity still remain.

Background Occupational exposure of bricklayers, construction workers, tile setters etc. has changed during the last years. For some years now, all manually handled cement in the European Union and in Switzerland is chromate-reduced. Epoxy resin systems are being used in more and more fields of application. Improved worker's protection, especially wearing protective gloves, is promoted. These changes influence the spectrum of occupational contact sensitization. Objective Description of the current allergen spectrum in patients working in the building trade who suffer from occupational contact dermatitis. Material and methods Retrospective analysis of data of the Information Network of Departments of Dermatology (IVDK), 2009 - 2011. Results During the study period, 245 bricklayers, construction workers, tile setters etc. with occupational dermatitis have been patch tested. Potassium dichromate was the most frequent allergen, yielding 15.1% positive reactions, followed by epoxy resin with 13.7% positive reactions. Beyond that, there were 8 additional components of epoxy resin systems (5 reactive diluents and 3 amine hardeners), as well as 9 rubber ingredients, mainly thiurams, among the 30 most frequent allergens. In the course of time, a decline of chromate sensitization could be noted, paralleled by a decline of cobalt sensitization. In contrast, sensitization to epoxy resin has increased. Conclusion Thanks to the usage of chromate-reduced cement, chromate sensitization continues to decline in the building trade. The increase of epoxy resin sensitization must prompt intensified prevention efforts. When recommending protective gloves, thiuram-free products should be preferred. The most important allergens are covered by the following test series recommended by the German Contact Dermatitis Research Group (DKG): DKG baseline series, DKG test series "building trade", DKG rubber series.

Background Synthetic fragrances and natural essential oils (EOs) are used in perfumery and found in various cosmetics. Essential oils are also increasingly used to promote wellness. In previous studies, the sensitization potential of some EOs has been identified; however, the current prevalence of sensitivity is largely unknown. Objectives The aim of this study was to determine frequency of positive patch-test reactions to EOs tested in the baseline series, along with 3 fragrance markers (FMs) (fragrance mix I, fragrance mix II, and Myroxylon pereirae), in consecutive patients in the US/Canadian North American Contact Dermatitis Group (NACDG) (2009-2014) and the central European, trinational Information Network of Departments of Dermatology (IVDK) (2010-2014). Methods This study used a retrospective analysis of patch-test results and relevant demographic/clinical data collected electronically by the networks, obtained with Santalum album 10% petrolatum (pet) (IVDK only); Cananga odorata 2% (NACDG) and 10% (IVDK) pet; Jasminum species 2% (NACDG) and 5% (IVDK) pet; Mentha piperita 2% pet; Melaleuca alternifolia, oxidized (tea tree oil), 5% pet; and Lavandula angustifolia 2% pet (latter 3 NACDG only). Results Overall, 62,354 patients were tested to 3 FMs and EOs (NACDG, 13,398; IVDK, 48,956); 11,568 (18.6%) reacted to at least 1 FM or EO, whereas 857 (1.4%) reacted to 1 or more EOs but none of the 3 FMs. For both the NACDG and IVDK populations, individuals who were positive to 1 or more of the 9 study allergens were significantly less likely to be male, have occupational skin disease, or have hand involvement and significantly more likely to have leg dermatitis and be 40 years and older (P's ≤ 0.005). Prevalence rates for EOs were as follows: S. album, 1.4% IVDK; C. odorata, 1.1% NACDG and 2.4% IVDK; Jasminum species, 0.7% NACDG and 1.4% IVDK; M. piperita, 0.9% NACDG; L. angustifolia, 0.3% NACDG; and M. alternifolia, 0.3% NACDG. Of the 140 NACDG patients who reacted to 1 or more of the 5 NACDG EOs but none of the FMs, M. alternifolia yielded most positive reactions (45%); half of these reactions were strong (++ or +++, 50.8%) and of definite/probable clinical relevance (52.4%). Of the 717 IVDK patients who reacted to 1 or more of the 3 IVDK EOs but none of the 3 FMs, 38% were positive to C. odorata, 38% to S. album and 36% to Jasminum species.' Conclusions Testing to EOs may be important for detecting sensitivity not detected by FMs alone. In North America, M. alternifolia is an important and clinically relevant sensitizer often not detected by FM. In Europe, as well as in North America, clinical relevance is often difficult to evaluate because (1) labeling of EOs when used as fragrance is not mandatory, and (2) these mixtures may indicate sensitization to 1 or more of their individual constituents from other sources, including synthetic fragrances.

Die Vermittlung von Wissen zu Risikofaktoren sowie Schutzverhalten stellt eine wesentliche Grundlage der primaren Hautkrebspravention dar. Die tatsachlich von der Bevolkerung genutzten Informationskanale sind auf diesem Gebiet weitgehend unbekannt. Deskriptive Darstellung der einschlagigen Informationsquellen, die Eltern von 3‑ bis 6‑jahrigen Kindern als besonders relevante Zielgruppe nutzen, sowie Analyse von Zusammenhangen zwischen soziodemografischen Faktoren, Arten von Informationsquellen und dem Wissensstand. Querschnittsstudie mittels selbstausgefulltem Fragebogen mit Onlineoption von Oktober 2011 bis Februar 2012 mit 3129 Familien, deren Kind einen der teilnehmenden Kindergarten des Landkreises Erlangen-Hochstadt bzw. der Stadt Erlangen und der Stadt Ansbach besuchten (87,5 % Response auf Kindergartenebene, 56,5 % auf Ebene der Beobachtungseinheit [Familie]). Es bestanden relativ geringe strukturelle Unterschiede zwischen den Standorten. Das Internet wurde von nur 13,3 % der Befragten genutzt. Eine positive Assoziation zwischen Nutzung mehrerer Informationsquellen und relevantem Wissen sowie praventivem Verhalten war zu verzeichnen. Daruber hinaus konnte eine negative Assoziation zwischen Nutzung des Internets und erworbenem Wissen festgestellt werden. Demgegenuber war die Nutzung von Printmedien sowie audiovisueller bzw. personlich vermittelter Information positiv mit Wissen assoziiert. Pravention sollte verstarkt auf Teile der Bevolkerung mit geringerer formaler Bildung zugeschnitten werden. Bei der Wissensvermittlung scheint derzeit dem Internet keine grose Bedeutung zuzukommen; die negative Assoziation zwischen Internetnutzung und Wissen ist moglicherweise auf verbreitete irrefuhrende Informationen zuruckzufuhren.

BACKGROUND Work-related skin diseases (WSD) are caused or worsened by a professional activity. Occupational skin diseases (OSD) need to fulfil additional legal criteria which differ from country to country. OSD range amongst the five most frequently notified occupational diseases (musculoskeletal diseases, neurologic diseases, lung diseases, diseases of the sensory organs, skin diseases) in Europe. OBJECTIVE To retrieve information and compare the current state of national frameworks and pathways to manage patients with occupational skin disease with regard to prevention, diagnosis, treatment and rehabilitation in different European countries. METHODS A questionnaire-based survey of the current situation regarding OSD patient management pathways was carried out with experts on occupational dermatology and/or occupational medicine from 28 European countries contributing to the European Cooperation in Science and Technology (COST) Action TD 1206 (StanDerm) (www.standerm.eu). RESULTS Besides a national health service or a statutory health insurance, most European member states implemented a second insurance scheme specifically geared at occupational diseases [insurance against occupational risks (synonyms: insurance against work accidents and occupational injuries; statutory social accident insurance)]. Legal standards for the assessment of occupationally triggered diseases with a genetic background differ between different countries, however, in most European member states recognition as OSD is possible. In one-third of the countries UV light-induced tumours can be recognized as OSD under specific conditions. CONCLUSION OSD definitions vary between European countries and are not directly comparable, which hampers comparisons between statistics collected in different countries. Awareness of this fact and further efforts for standardization are necessary.

Wearing of occlusive gloves during the whole working shift is considered a risk factor for developing hand eczema, similar to wet work. Moreover, the increased hydration due to glove occlusion may lead to brittle nails. Two hundred and seventy clean room workers, wearing occlusive gloves for prolonged periods, and 135 administrative employees not using gloves were investigated. This included a dermatological examination of the nails and the hands, using the Hand Eczema ScoRe for Occupational Screening (HEROS), measurement of transepidermal water loss (TEWL), and a standardized interview. Of the clean room workers, 39%, mainly women, reported nail problems, mostly brittle nails with onychoschisis. Skin score values showed no significant differences between HEROS values of both groups. TEWL values of exposed subjects were similar to TEWL values of controls 40 min after taking off the occlusive gloves. In a multiple linear regression analysis, male gender and duration of employment in the clean room were associated with a significant increase in TEWL values. The effect of occlusion on TEWL seems to be predominantly transient and not be indicative of a damaged skin barrier. This study confirmed the results of a previous investigation showing no serious adverse effect of wearing of occlusive gloves on skin condition without exposure to additional hazardous substances. However, occlusion leads to softened nails prone to mechanical injury. Therefore, specific prevention instructions are required to pay attention to this side effect of occlusion.

BACKGROUND We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. METHODS We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratified by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-effects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6·6 years (IQR 5·8-7·6), no patients had any grade 4 toxities, and three (

Linked article: Bruze et al. Br J Dermatol 2020; 182:955–964.

Background The aim of this study was to evaluate the efficacy and safety of chemoradiotherapy (RCT) combined with regional deep hyperthermia (RHT) of high-risk bladder cancer after transurethral resection of bladder tumor (TUR-BT). Materials and methods Between 1982 and 2016, 369 patients with pTa, pTis, pT1, and pT2 cN0–1 cM0 bladder cancer were treated with a multimodal treatment after TUR-BT. All patients received radiotherapy (RT) of the bladder and regional lymph nodes. RCT was administered to 215 patients, RCT + RHT was administered to 79 patients, and RT was used in 75 patients. Treatment response was evaluated 4–6 weeks after treatment with TUR-BT. Results Complete response (CR) overall was 83% (290/351), and in treatment groups was RT 68% (45/66), RCT 86% (178/208), and RCT + RHT 87% (67/77). CR was significantly improved by concurrent RCT compared with RT (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.05–5.12; p = .037), less influenced by hyperthermia (OR, 2.56; 95% CI, 0.88–8.00; p = .092). Overall survival (OS) after RCT was superior to RT (hazard ratio [HR], 0.7; 95% CI, 0.50–0.99; p = .045). Five-year OS from unadjusted Kaplan-Meier estimates was RCT 64% versus RT 45%. Additional RHT increased 5-year OS to 87% (HR, 0.32; 95% CI, 0.18–0.58; p = .0001). RCT + RHT compared with RCT showed a significantly better bladder-preservation rate (HR, 0.13; 95% CI, 0.03–0.56; p = .006). Median follow-up was 71 months. The median number of RHT sessions was five. Conclusion The multimodal treatment consisted of a maximal TUR-BT followed by RT; concomitant platinum-based chemotherapy combined with RHT in patients with high-grade bladder cancer improves local control, bladder-preservation rate, and OS. It offers a promising alternative to surgical therapies like radical cystectomy. Implications for Practice Radical cystectomy with appropriate lymph node dissection has long represented the standard of care for muscle-invasive bladder cancer in medically fit patients, despite many centers reporting excellent long-term results for bladder preserving strategies. This retrospective analysis compares different therapeutic modalities in bladder-preservation therapy. The results of this study show that multimodal treatment consisting of maximal transurethral resection of bladder tumor followed by radiotherapy, concomitant platinum-based chemotherapy combined with regional deep hyperthermia in patients with Ta, Tis, T1–2 bladder carcinomas improves local control, bladder-preservation rate, and survival. More importantly, these findings offer a promising alternative to surgical therapies like radical cystectomy. The authors hope that, in the future, closer collaboration between urologists and radiotherapists will further improve treatments and therapies for the benefit of patients.

Background: The use of methylisothiazolinone (MI) in cosmetic products has caused an unprecedented epidemic of MI contact allergy. Current data concerning exposures at a European level are required. Objectives: To describe demographics and MI exposures for European patients with MI contact allergy. Methods: Eleven European dermatology departments from eight European countries prospectively collected data between 1 May and 31 October 2015 among consecutive patients who had positive patch test reactions to MI (2000ppm aq.). Results: A total of 6.0% (205/3434; range 2.6-13.0%) of patients had positive patch test reactions to MI. Dermatitis most frequently affected the hands (43.4%), face (32.7%), arms (14.6%), and eyelids (11.7%); 12.7% had widespread dermatitis. For 72.7% (149/205), MI contact allergy was currently relevant mainly because of exposure to cosmetic products (83.2%; 124/149). Of these 124 patients, 19.5% were exposed to leave-on and rinse-off cosmetic products, 24.8% only to leave-on cosmetic products and 38.9% only to rinse-off cosmetic products containing MI or methylchloroisothiazolinone/MI. The majority of these (79%) noted onset of their dermatitis between 2013 and 2015. Fifteen patients (7.3%) had previously experienced allergic reactions when they were in newly painted rooms. Conclusion: Clinically relevant MI contact allergy remains prevalent across European countries, mainly because of exposure to rinse-off and leave-on cosmetic products. (Less)

SummaryBackground Rubber additives constitute an important group of contact allergens, particularly in certain occupations. Objectives To collect information regarding the current practice of using a ‘rubber series’ in Europe, and discuss this against the background of evidence concerning the prevalence of allergy in order to derive a recommendation for a ‘European rubber series’. Methods The following were performed: (i) a survey targeting all members of the COST action ‘StanDerm’ consortium, (ii) analysis of rubber contact allergy data in the database of the European Surveillance System on Contact Allergies, and (iii) a literature review. Results Information from 13 countries was available, from one or several departments of dermatology, and occasionally occupational health. Apart from some substances tested only in single departments, a broad overlap regarding important allergens was evident, but considerable variation existed between departments. Conclusions An up-to-date ‘European rubber series’ is recommended, with the exclusion of substances only of historical concern. A ‘supplementary rubber series’ containing allergens of less proven importance, requiring further analysis, is recommended for departments specializing in occupational contact allergy. These should be continually updated as new evidence emerges.

Case reports constitute a classic publication format that is being increasingly appreciated, for example because of its educational value. In the field of contact dermatitis research, case reports often serve as sentinel publications concerning new allergens, or new exposures to known allergens, or regarding other conditions leading to contact dermatitis. The CARE guideline published in 2013 addresses standardized and complete reporting of case reports in all fields of medicine. The present article takes up the CARE suggestions, and further specifies these in terms of application to case reports in the field of contact dermatitis. The objective of this structured guidance is to provide junior or inexperienced doctors and researchers with an annotated list, against which the fulfilment of essential or optional items of a complete, high-quality case report to be submitted to Contact Dermatitis or other journals can be checked.

To evaluate the feasibility and efficacy of external beam three-dimensional (3D) conformal accelerated partial breast irradiation (APBI) for selected patients with early breast cancer. Between 2011 and 2016, 72 patients were recruited for this prospective phase 2 trial. Patients were eligible for APBI if they had histologically confirmed breast cancer or pure ductal carcinoma in situ (DCIS), a tumor diameter ≤3 cm, clear resection margins ≥2 mm, no axillary lymph node involvement, no distant metastases, tumor bed clips, and were aged ≥50 years. Patients were excluded if mammography showed a multicentric invasive growth pattern, or if they had residual diffuse microcalcifications postoperatively, an extensive intraductal component, or vessel invasion. Patients received 3D conformal external beam APBI with a total dose of 38 Gy in 10 fractions in 1–2 weeks. The trial had been registered at the German Clinical Trials Register, DRKS-ID: DRKS00004417. Median follow-up was 25.5 months (range 1–61 months). Local control was maintained in 71 of 72 patients. The 3‑year local recurrence rate was 2.1% (95% confidence interval, CI: 0–6.1%). Early toxicity (grade 1 radiodermatitis) was seen in 34.7% (25/72). Late side effects ≥ grade 3 did not occur. Cosmetic results were rated as excellent/good in 96.7% (59/61). APBI with external beam radiotherapy techniques is feasible with low toxicity and, according to the results of the present and other studies, on the way to becoming a standard treatment option for a selected subgroup of patients.

Substantial public health efforts have been undertaken throughout the last 25years to increase awareness about skin cancer risks in the German population. An evaluation of long-term effects of these awareness campaigns and preventive activities on the population level and in specific subgroups is yet lacking. We address the temporal development of knowledge about skin cancer risk factors and agreement to the necessity of sun protection in different outdoor situations among parents of young children. We compiled data from four population-based surveys comprising data from 8184 parents of 3- to 6-year-old children in two regions of Germany performed over a nineteen-year period between 1993 and 2012. These individual cross-sectional studies used an identical methodology to recruit study subjects and to assess the principal outcome measures. Overall, parental knowledge about skin cancer risk factors and agreement to the necessity of sun protection improved significantly over the nineteen-year period. For instance, the recognition of fair skin/hair, sunburns during childhood and a high number of naevi, respectively, being risk factors for skin cancer increased by 20.0%, 19.9% and 19.2% from the first to the most recent survey. Two remaining knowledge gaps became evident: (i) the underrating of intermittent intensive sun exposure as a skin cancer risk factor and (ii) the erroneous belief that clouds provide sufficient sun protection at midday during summertime. The messages of future public health campaigns in Germany addressing skin cancer risks and informing about preventive measures for sun protection should thus be refined regarding these aspects.

Purpose The aim of this study was to give an overview of the prevalence of contact allergy to active ingredients and excipients of topical medications across Europe. Methods Retrospective analysis of data collected by the European Surveillance System on Contact Allergies (www.essca-dc.org) with substances applied to consecutively patch tested patients, 2009–2012, in 54 departments in 12 European countries. Results In view of the varying composition of the baseline series used in the previously mentioned departments and countries, between 58 833 (lanolin alcohols) and 16 498 patients (sodium metabisulfite) were patch tested with the topical agents covered in this study. Among these, positive (allergic) reactions were most commonly observed to sodium metabisulfite (3.12% positive), followed by propolis (2.48%), Compositae mix (1.73%), lanolin alcohols (1.65%) and caine mix III (benzocaine, cinchocaine and tetracaine; 1.27%). Conclusions Several of the substances warrant routine screening for contact allergy, i.e. patch testing in a baseline series. However, in view of a vast number of other topical agents, additional patch testing with the suspect topical drug preparations (including natural remedies and cosmetics) is warranted. In the event of a positive test to the (pharmaceutical) product, single ingredients should be tested individually to precisely identify the hapten(s). Copyright © 2016 John Wiley & Sons, Ltd.

BACKGROUND AND PURPOSE To compare early side effects and patient compliance of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to external beam whole breast irradiation (WBI) in a low-risk group of patients with breast cancer. MATERIAL AND METHODS Between April 2004 and July 2009, 1328 patients with UICC stage 0-IIA breast cancer were randomized to receive WBI with 50Gy and a boost of 10Gy or APBI with either 32.0Gy/8 fractions, or 30.1Gy/7 fractions (HDR-brachytherapy), or 50Gy/0.60-0.80Gy per pulse (PDR-brachytherapy). This report focuses on early side-effects and patient compliance observed in 1186 analyzable patients. ClinicalTrials.gov identifier: NCT00402519. RESULTS Patient compliance was excellent in both arms. Both WBI and APBI were well tolerated with moderate early side-effects. No grade 4 toxicity had been observed. Grade 3 side effects were exclusively seen for early skin toxicity (radiation dermatitis) with 7% vs. 0.2% (p

Background The purpose of this study was to evaluate risk factors that influence overall survival (OS)/disease-free survival (DFS)/locoregional recurrence-free survival (LRFS), and distant metastases-free survival (DMFS) in patients with high-risk primary salivary gland carcinoma who underwent surgery and postoperative (chemo)radiotherapy with curative intention. Methods We reviewed data of 63 patients with high-risk primary salivary gland carcinoma in a retrospective single-center audit. Results At a median follow-up of 31 months (range, 5–145 months), cumulative OS and DFS were 91.7%, 77.6%, and 62.9%, and 82.1%, 65.6%, and 57.7%, respectively, after 1, 2, and 5 years. LRFS and DMFS were 92%, 86%, and 86%, and 83.4%, 70.4%, and 62.3% after 1, 2, and 5 years, respectively. Of all patient-related, tumor-related, and treatment-related factors, high-grade histology (G3) was the only factor in univariate and multivariate analysis that was predictive for a shorter DMFS (low/intermediate vs high-grade: 100%, 100%, and 89.4% vs 72.9%, 54.3%, and 42.8% after 1, 2, and 5 years, respectively) and a shorter DFS (low/intermediate vs high-grade: 100%, 90%, and 84.4% vs 71.2%, 50.1%, and 39.4% after 1, 2, and 5 years, respectively) and OS (low/intermediate vs high-grade: 100%, 100%, and 86.5% vs 86.5%, 63.2%, and 46.5% after 1, 2, and 5 years, respectively). Conclusion High-grade tumor histology is a highly significant predictor of a shorter DMFS, OS, and DFS in salivary gland carcinoma, irrespective of histological subtype. © 2016 Wiley Periodicals, Inc. Head Neck, 2016

A preliminary study suggests that intestinal-wall assessment by means of noninvasive multispectral optoacoustic tomography may distinguish remission from active disease in patients with Crohn’s disease.

Background: The members of the Task Force on Contact Dermatitis and the Task Force on Occupational Dermatoses of the European Academy of Dermatology and Venereology (EADV), of the European Dermatology Forum (EDF), and the members of the UEMS Section of Dermatology-Venereology (UEMS-EBDV) we want to vindicate the fundamental role that the specialist in Dermatology has in the diagnosis and management of Immuno-mediated /allergic Diseases. Objective: In disagreement with the blueprint paper of the UEMS section of Allergology (2013), in which dermatologists are excluded from one of their core activities it was decided to write this consensus paper. Discussion: The skin occupies a crucial place in the broad spectrum of allergic diseases; there is no other organ with such a multitude of different clinical conditions mediated by so many pathogenetic immune mechanisms. Subsequently, dermatologists play a fundamental role in the management of immune-mediated diseases including among others contact dermatitis, atopic dermatitis, urticaria and angioedema or cutaneous adverse drug, food and arthropod reactions. The essential role of dermatology in the diagnostic, therapeutic and preventive management of immune mediated /allergic diseases which is crucial for patient management is justified from both the academic and professional point of view. Conclusion: Based on the best care of the patient with cutaneous immune allergic disease a multidisciplinary approach is desirable and the dermatologist has a pivotal role in patient management. Be so good and no one will not ignore you, dermatologist. Ideally Dermatology should be governed according the following Henry Ford statement: “Arriving together is the beginning; keeping together is progress; working together is success.”. (Less)

Background SB2 is a biosimilar infliximab approved for the treatment of inflammatory bowel disease (IBD) patients. These are the first prospective data investigating long-term efficacy, safety, and pharmacokinetics after switching from infliximab originator to biosimilar SB2 in IBD patients. Methods This is a prospective, observational cohort study of patients that underwent a switch from infliximab originator to biosimilar SB2 in 2017 as part of routine care at the outpatient Clinic for IBD at the University Hospital of Erlangen, Germany. Long-term safety and clinical effectiveness were recorded over a follow-up period of 18-months. Clinical disease activity was assessed by the Harvey–Bradshaw Index (HBI) in Crohn’s disease (CD) and the partial Mayo Score (pMS) in ulcerative colitis (UC) patients. C-reactive protein (CRP) was analyzed at every patient visit, and IFX trough-level (TL) and anti-IFX antibodies (ADA) were measured prior to every SB2 administration, using the Promonitor® tests. The occurrence of adverse events was registered at every patient visit. Results A total of 148 IBD patients (96 CD, 52 UC) was enrolled. The median duration of previous infliximab treatment before the switch was 29 months (range 1.0–110.0). Median disease activity in CD was an HBI of 3 (0–16) at switch (baseline), 2 (0–13) at month 6, 3 (0–15) at month 12 and 2.5 (0–11) at month 18. Median disease activity in UC was a pMS of 0 (0–6) at baseline, 1 (0–4) at month 6, 1 (0–4) at month 12 and 1 (0–5) at month 18. The median TL for all IBD patients was 6.3 mg/ml (0.1–33.7) at baseline, 5.0 mg/ml (0.1–34.3) at month 6, 6.3 mg/ml (0.1–35.8) at month 12 and 5.1 mg/ml (0.1–35.4) at month 18. CRP for all IBD patients was 2.2 mg/l (0.1–45.6) at baseline, 2.2 mg/l (0.1–90.4) at month 6, 2.3 mg/l (0.1–169.5) at month 12 and 2.7 mg/l (0.1–19.8) at month 18. In the 18-month follow-up period, 12/103 (11.7%) of patients who were ADA-negative at baseline developed ADA post-switch. Altogether, 40 (27%) IBD patients discontinued SB2 treatment during the 18-month follow-up period (4 anaphylaxis, 20 loss of response, 7 non-serious and 9 serious adverse events), 2 paused during pregnancy, 1 discontinued in clinical remission, 10 were lost to follow-up (7 change of physician, 3 unknown). Serious adverse events comprised 3 malignancies (breast and prostate carcinoma, neuroendocrine malignancy), 1 liver abscess and 5 intestinal surgical procedures (1 perforation, 1 ileus, and 3 stenoses). Conclusion Switching from IFX originator to biosimilar SB2 was not associated with an increase in disease activity. No clinically meaningful changes in IFX trough levels or immunogenicity were identified. Altogether, SB2 was well tolerated in a real-life setting.

BACKGROUND For early detection of initial skin changes in occupational screenings, only few objective assessment systems are available. OBJECTIVES With the aim of assessing an objective measurement method for hand eczema, we trialed the application of the tissue viability imaging (TiVi) system, quantifying erythema non-invasively by polarized light spectroscopy. MATERIALS AND METHODS In a field study with 625 employees of a semiconductor production company, 411 were exposed to prolonged wearing of occlusive gloves in the clean room. TiVi system and Hand Eczema Score for Occupational Screenings (HEROS), a quantitative skin score for the hands, were used, supplemented by a standardized personal interview. RESULTS TiVi values of 65 up to 246 for each hand (palm or back), for each participant summed to overall 289 up to 848 (median 389), were measured. Higher TiVi values were noted for men, smokers, and with increasing age. Correlation between TiVi and HEROS was only weak. Several factors like skin pigmentation, thickness of the skin, or tattoos seem to influence TiVi results. CONCLUSIONS The practical relevance of one-time measurements with the TiVi system in occupational screenings seems to be limited. Specifically, the TiVi system cannot replace dermatological examinations at the workplace. Notwithstanding, the application for other scientific purposes might be useful.

Overexposure to ultraviolet (UV) radiation is the main modifiable risk factor for skin cancer. The Global Solar Ultraviolet Index (UVI) was introduced as a tool to visualize the intensity of UV radiation on a certain day which should enable and encourage people to take appropriate protective measures. The exposure category ‘low’ of the UVI, including values from 0 to 2, was linked to the health message ‘No protection required’ by the World Health Organization and collaborating centres. However, published evidence corroborating this advice is scarce. Therefore, we analysed ambient erythemal irradiance data of 14,431 daily UVI time series of low UVI days. Data were gathered at nine stations of the German solar UV monitoring network – covering all major climate areas in Germany – in the years 2007 ­­­- 2016. We compared ambient erythemal doses calculated for various time intervals with average minimal erythemal doses (MEDs) of the Caucasian Fitzpatrick skin phototypes I-IV to assess the potential for skin damage arising from sun exposure on days with low UVI values. The most common months for the occurrence of days with low UVI values in our dataset were January and December, February and November, and March and October for UVI 0, 1 and 2, respectively. Our results indicate that on days with a UVI value of 0, risk of deterministic radiation injury (solar erythema) is negligible. Conversely, the above-mentioned health message appears misleading when melano-compromised individuals spend several hours outdoors on days with a UVI value of 2, as median doses exceed the MEDs of Fitzpatrick skin types I and II after an exposure duration of only 2h around solar noon. Under very rare specific circumstances, MEDs of those two most sensitive skin types can also be exceeded even on days with UVI 1. Hence, two aspects of current public health messages may need reconsideration: on the one hand, the health message related to an ‘innocuous level’ of the UVI and, on the other hand, a possible adaption of UVI-related health messages to different skin types.

To compare results after chemoradiotherapy with and without deep regional hyperthermia in patients with anal cancer. Between 2000 and 2015, a total of 112 consecutive patients with UICC stage I–IV anal cancer received chemoradiotherapy with 5‑fluororuracil and mitomycin C (CRT). In case of insufficient tumor response 4–6 weeks after chemoradiotherapy, patients received an interstitial pulsed-dose-rate brachytherapy boost. Additionally, 50/112 patients received hyperthermia treatments (HCRT). Median follow-up was 41 (2–165) months. After 5 years follow-up, overall (95.8 vs. 74.5%, P = 0.045), disease-free (89.1 vs. 70.4%, P = 0.027), local recurrence-free (97.7 vs. 78.7%, P = 0.006), and colostomy-free survival rates (87.7 vs. 69.0%, P = 0.016) were better for the HCRT group. Disease-specific, regional failure-free, and distant metastasis-free survival rates showed no significant differences. The adjusted hazard ratios for death were 0.25 (95% CI, 0.07 to 0.92; P = 0.036) and for local recurrence 0.14 (95% CI, 0.02 to 1.09; P = 0.06), respectively. Grades 3–4 early toxicities were comparable with the exception of hematotoxicity, which was higher in the HCRT group (66 vs. 43%, P = 0.032). Incidences of late side effects were similar with the exception of a higher telangiectasia rate in the HCRT group (38.0 vs. 16.1%, P = 0.009). Additional regional hyperthermia improved overall survival, local control, and colostomy rates. Its potential beneficial role has to be confirmed in a prospective randomized setting. Therefore, the HyCAN trial has already been established by our group and is currently recruiting patients (Clinicaltrials.gov identifier: NCT02369939).

The reporting of scientific results (in the field of contact dermatitis/allergy) should include a description of the methods used, including, but not limited to, standardized patch testing. Several aspects always need to be reported, such as duration of exposure, reading times, vehicle, and concentration of allergens. However, concerning other aspects, explicit compliance with international patch testing guidelines, notably the European Society of Contact Dermatitis guideline, which covers all relevant general aspects, is deemed to be a sufficient description of methods, supplemented by study-specific information, including partial non-compliance with the guideline, as indicated. Besides technical aspects, the quality of reporting of scientific results has several other dimensions, including epidemiological and biostatistical aspects discussed in this article. Prospectively, when a study is planned, performed, and reported, issues such as selection of patients and sample size and their impact on power and precision, the role of misclassification and potential conflicts of interests need to be addressed and discussed, respectively. Retrospectively, when a study is read and analysed, all relevant aspects of quality should be considered when the weight of evidence that a study publication provides is evaluated. Employing rigid 'quality criteria' may have the detrimental effect of relevant, if slightly imperfect, evidence being deliberately excluded.