Patch testing with hair cosmetic series in Europe: a critical review and recommendation.

Many key ingredients of hair cosmetics (in particular, dyes, bleaches, and hair-styling agents) are potent (strong to extreme) contact allergens. Some heterogeneity is apparent from published results concerning the range of allergens for which patch testing is important. The objective of the present review was to collect information on the current practice of using 'hair cosmetic series', and discuss this against the background of evidence concerning consumer/professional exposure and regulatory aspects to finally derive a recommendation for a 'European hair cosmetic series'. The methods involved (i) a survey targeting all members of the COST action 'StanDerm' (TD1206) consortium, (ii) analysis of data in the database of the European Surveillance System on Contact Allergies (ESSCA), and (iii) literature review. Information from 19 European countries was available, partly from national networks, and partly from one or several departments of dermatology or, occasionally, occupational medicine. Apart from some substances being tested only in single departments, a broad overlap regarding 'important' allergens was evident. Some of the substances are no longer permitted for use in cosmetics (Annex II of the Cosmetics Regulation). An up-to-date 'European hair cosmetics series', as recommended in the present article, should (i) include broadly used and/or potent contact allergens, (ii) eliminate substances of only historical concern, and (iii) be continually updated as new evidence emerges.

Patch test results with fragrance markers of the baseline series - analysis of the European Surveillance System on Contact Allergies (ESSCA) network 2009-2012.

BACKGROUND: Contact allergy to fragrances is common, and impairs quality of life, particularly in young women. OBJECTIVE: To provide current results on the prevalences of sensitization to fragrance allergens used as markers in the baseline series of most European countries. METHODS: Data of patients consecutively patch tested between 2009 and 2012 in 12 European countries with fragrance allergens contained in the baseline series were collected by the European Surveillance System on Contact Allergies network and descriptively analysed. Four departments used the TRUE Test(®) system. RESULTS: The 'basic markers' were tested on 51 477 [fragrance mix II (FM II)] to 57 123 [Myroxylon pereirae, balsam of Peru] patients, and yielded positive reactions as follows: fragrance mix I 6.9%, Myroxylon pereirae 5.4%, FM II 3.8%, colophonium 2.6%, and hydroxyisohexyl 3-cyclohexene carboxaldehyde 1.7%, with some regional differences. Prevalences with TRUE Test(®) allergens were lower. Additional fragrances were tested on 3643 (trimethylbenzenepropanol) to 14 071 (oil of turpentine) patients, and yielded between 2.6% (Cananga odorata) and 0.7% (trimethylbenzenepropanol) positive reactions. CONCLUSIONS: Contact allergy to fragrances is common throughout Europe, with regional variation probably being explained by patch test technique, and differences in exposure and referral patterns. The current basic markers of fragrance sensitivity in the baseline series should be supplemented with additional fragrance allergens.

Characteristics of patients patch tested in the European Surveillance System on Contact Allergies (ESSCA) network, 2009-2012.

BACKGROUND: Patch test results often vary between departments, and also between countries. Such variation may be partly attributable to systematic effects introduced by patient characteristics, differing exposures, patient selection, or methodological differences. OBJECTIVE: To examine the amount of variation of patient characteristics in terms of the MOAHLFA index and of the proportion of patients with at least one positive reaction to the (European) baseline series ('P' measure), and to examine potential reasons for the variation. METHODS: A retrospective analysis was performed of patch test data from 63 530 consultations collected by 53 departments from 12 countries participating in the European Surveillance System on Contact Allergies (ESSCA) ( www.essca-dc.org) between 2009 and 2012. RESULTS: Considerable variation in the prevalence of the MOAHLFA factors between departments was found, caused, for example, by differing specializations (e.g. occupational dermatology) or patient characteristics. Notable variation concerning the 'P' measure was observed; however, larger national networks (contributing to the ESSCA) tend to have quite similar ranges of this measure. CONCLUSIONS: Data from one department per country give valuable insights into the spectrum of contact allergy prevalence rates in that country, but are not as representative as national data pooled from several departments.

Monitoring contact sensitization to p-phenylenediamine (PPD) by patch testing with PPD 0.3% in petrolatum.

BACKGROUND: Being a contact allergen of general relevance, p-phenylenediamine (PPD) is patch tested in the baseline series. However, PPD 1% in petrolatum may actively sensitize. Patch testing with PPD at 0.35% pet. proved to be safe, as far as active sensitization is concerned. OBJECTIVES: To determine whether PPD 0.3% pet. reliably detects PPD sensitization. METHODS: Patch testing with PPD 0.3% pet. and 1% pet. synchronously was performed in consecutive patients in a multicentre study within the Information Network of Departments of Dermatology. RESULTS: Altogether, 2042 patients were patch tested. PPD 1% pet. yielded 6.0% positive reactions (n = 123), and PPD 0.3% pet. yielded 4.7% (n = 95). The synchronous reproducibility of PPD reactions was similar as known from parallel patch tests with identical PPD concentrations. The diagnostic properties of PPD 0.3% pet. expressed as reaction index and positivity ratio were good. Of the 123 patients reacting to PPD 1% pet., 32 (26%) had no positive reaction to PPD 0.3% pet. In 22 of these 32 patients (69%), no clinical relevance could be found. CONCLUSIONS: As patch testing with PPD 0.3% pet. is reliable according to our results, we recommend replacing PPD 1% pet. in the baseline series with PPD 0.3% pet.

Current patch test results with the European baseline series and extensions to it from the 'European Surveillance System on Contact Allergy' network, 2007-2008.

BACKGROUND: The pattern of contact sensitization to the supposedly most important allergens assembled in the baseline series differs between countries, presumably at least partly because of exposure differences. Objectives. To describe the prevalence of contact sensitization to allergens tested in consecutive patients in the years 2007 and 2008, and to discuss possible differences. METHODS: Data from the 39 departments in 11 European countries comprising the European Surveillance System on Contact Allergy network (www.essca-dc.org) in this period have been pooled and analysed according to common standards. RESULTS: Patch test results with the European baseline series, and country-specific or department-specific additions to it, obtained in 25 181 patients, showed marked international variation. Metals and fragrances are still the most frequent allergens across Europe. Some allergens tested nationally may be useful future additions to the European baseline series, for example methylisothiazolinone, whereas a few long-term components of the European baseline series, namely primin and clioquinol, no longer warrant routine testing. CONCLUSIONS: The present analysis points to 'excess' prevalences of specific contact sensitization in some countries, although interpretation must be cautious if only few, and possibly specialized, centres are representing one country. A comparison as presented may help to target in-depth research into possible causes of 'excess' exposure, and/or consideration of methodological issues, including modifications to the baseline series.

The 'overall yield' with the baseline series - a useful addition to the array of MOAHLFA factors describing departmental characteristics of patch tested patients.

BACKGROUND: The proportion of patients with a positive patch test reaction to at least one allergen from the baseline series differs between departments. OBJECTIVES: To further define the above mentioned proportion, termed the 'P' measure, to examine factors associated with this measure, to describe its variation over time and between centres, and to discuss possible uses. PATIENTS AND METHODS: Eighteen departments have been 'long-term' participants in the Information Network of Departments of Dermatology (IVDK; www.ivdk.org), that is, since 1995 (1997 in two cases). In these departments, 80 919 consultations for patch testing with the baseline series, in the composition of the series valid at that time, were documented until December 2009. Bivariate and multifactorial analyses addressed factors associated with being patch test-positive to at least one baseline series allergen. RESULTS: Of the study population, 46.5% had at least one positive test reaction, with considerable variation being seen between centres and a general decline during the study period. Among other factors, female sex, occupational causation and a high suspicion of allergic contact dermatitis were significantly associated with having at least one positive patch test reaction to the baseline series. CONCLUSIONS: The 'P' measure should prove useful as another perspective on departmental characteristics, and should be reported along with established variables (MOAHLFA index).

Patch testing with hydroxyethyl-p-phenylenediamine sulfate - cross-reactivity with p-phenylenediamine.

BACKGROUND: Adverse reactions to permanent hair dyes are frequent, and primarily result from sensitization to p-phenylenediamine (PPD). OBJECTIVES: To investigate the degree of cross-reactivity to a chemically similar dye, hydroxyethyl-p-phenylenediamine sulfate (HPPS), and whether this might be a dyeing alternative for patients who are sensitive to PPD. METHOD: HPPS was patch tested in two concentrations in a total of 216 patients suspected of having contact dermatitis caused by hair dyes and/or hair cosmetics. A regular use test with a hair dye containing HPPS was suggested to every patient who had had an adverse reaction to a PPD hair dye in the past. RESULTS: Forty of 216 (19.9%) patients reacted to 1% PPD, whereas only 2/216 (0.9%) showed a positive reaction to 1% HPPS. Reactivity to 2% HPPS was only slightly higher (5/216, 2.3%). On the basis of the 43 PPD-positive patients, the reactivity to 2% HPPS amounted to 12%; the corresponding figure for toluene-2,5-diamine was 15% (5/33). In a use test on two PPD-positive patients with a hair dye containing HPPS, no adverse reaction was seen, even after several years of regular dyeing. CONCLUSIONS. HPPS may be an alternative hair dye for individuals not tolerating PPD-containing dyes. However, cross-reactivity with PPD and other aromatic amines may occur. HPPS is also a known sensitizer, and the risk of de novo sensitization can only be assessed by a controlled study on a large panel and under regular use conditions.

Patch testing with fragrance mix II: results of the IVDK 2005-2008.

BACKGROUND: The fragrance mix (FM I), established in 1977, detects the majority, but not all cases of contact allergy to fragrances. Based on European research 2002/2003, fragrance mix II (FM II) was developed to supplement FM I. In 2005, the German Contact Dermatitis Research Group (DKG) added FM II to their baseline series. OBJECTIVES: To evaluate reactions to FM II and its constituents in routine patch testing. METHODS: Retrospective data analysis of the Information Network of Departments of Dermatology (IVDK), 2005-2008, of patch test results with FM II and its constituents. RESULTS: A total of 35 633 patients were patch tested with FM II as part of the DKG baseline series. Of these, 1742 (4.9%) reacted positively. Concomitant reactions to FM I were observed in 41.9% of the patients reacting to FM II. In 367 FM II-positive patients, a full breakdown test of the mix was performed. Of these, 47.7% reacted to hydroxyisohexyl 3-cyclohexene carboxaldehyde, 16.1% to citral, 11.4% to farnesol, 3.8% to hexyl cinnamal, 2.7% to coumarin, and 2.5% to citronellol. CONCLUSIONS: FM II is an important screening and diagnostic tool to detect fragrance allergy. Hydroxyisohexyl 3-cyclohexene carboxaldehyde is the most important fragrance allergen in FM II.

Contact allergy to essential oils: current patch test results (2000-2008) from the Information Network of Departments of Dermatology (IVDK).

BACKGROUND: Essential oils are used in perfumery and in products for aromatherapy or balneotherapy. Previous studies have shown some to be important contact sensitizers. A practical diagnostic approach, based on the results of a large, central European network and other evidence, is needed. METHODS: Data of the Information Network of Departments of Dermatology (IVDK; www.ivdk.org) on all patients patch tested between January 2000 and December 2008 with essential oils were retrospectively analysed. RESULTS: 15 682 patients of 84 716 consulting in the period had been tested with at least one essential oil, and 637 reacted positively to at least one of the essential oils, most commonly to ylang-ylang oil (I and II) (3.1% as weighted mean of positive tests in special series and consecutive testing), lemongrass oil (1.8%), jasmine absolute (1.6%), sandalwood oil and clove oil (1.5% each). Cross-reactivity between distillate and main allergen, if available, was marked. CONCLUSIONS: Patch testing the important essential oils should be considered in patients with a suggestive history. Additionally, culprit products brought in by the patient should be tested, closing a diagnostic gap by (i) including those other essential oils not included in the commercial test series and (ii) providing a means of testing with the oxidized substances to which the patient had actually been exposed.

Contact allergy to fragrances: current patch test results (2005-2008) from the Information Network of Departments of Dermatology.

BACKGROUND: Contact sensitization to fragrances is common both in clinical and in population samples. The spectrum of allergens is broad and diverse, and to some extent covered by a set of screening agents. OBJECTIVES: To examine the current frequency of contact sensitization to fragrance allergens in patients routinely patch tested for suspected allergic contact dermatitis with the baseline series and special series. PATIENTS AND METHODS: Between 2005 and 2008, 40 709 patients were patch tested in the departments of the Information Network of Departments of Dermatology (http://www.ivdk.org). Results with selected fragrances were analysed. RESULTS: Of all patients tested with the German baseline series, 15.1% reacted positively to fragrance mix (FM) I (6.6% positive), FM II (4.6% positive) or Myroxylon pereirae resin (balsam of Peru, 6.8% positive). Among the single constituents of FM I, Evernia prunastri [oak moss absolute (abs.)] was the leading allergen, and amyl cinnamal the least frequent allergen. Among fragrances not included in FM I or FM II, Evernia furfuracea (tree moss abs.) was the most common allergen. CONCLUSIONS: For diagnostic purposes, it is necessary to combine several screening agents. The frequency of contact sensitization differs greatly between single fragrances.

Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study.

BACKGROUND: Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. OBJECTIVES: To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. METHODS: The study was performed as a multi-centre, cross-sectional study from 10 European clinics. All patients were patch tested, and severity of hand eczema assessed by Hand Eczema Severity Index. A multi-variate analysis was performed to explore which factors influenced severity, QoL and sick leave. RESULTS: A total 416 patients were included, and 63% had contact sensitisation to one or more of the tested allergens. More women (66%) than men (51%) were sensitized. No significant association was found between sensitisation to specific allergens, disease severity, QoL or diagnostic subgroups. High age, male sex, atopic eczema and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were independent risk factors for low QoL, as measured by Dermatology Life Quality Index, and atopic eczema as well as allergic contact dermatitis as subdiagnosis was associated with increased sick leave. CONCLUSION: Diagnostic subgroups were not found to be related to specific allergens. Contact sensitisation was found to be a risk factor for increased severity of hand eczema, as did high age, male sex and atopic eczema.

Quantitative patch and repeated open application testing in hydroxyisohexyl 3-cyclohexene carboxaldehyde sensitive-patients.

OBJECTIVE: To identify the concentration of the fragrance compound hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI) (HICC) that is sufficiently low not to cause an allergic reaction in patients with proven sensitization. METHODS: Repeated open application testing (ROAT) in 64 subjects with 2 preparations (perfume and cream) in different concentration (0.005-2.5%). Confirmatory patch testing with four preparations in two different concentrations (2.5% and 5%). RESULTS: The concentrations of HICC being tolerated by 90% of those sensitized to HICC are estimated as <88.2 ppm (cream) and <270 ppm (perfume) equivalent to 1.2 microg/cm(2) (perfume) and 4.9 microg/cm(2) (cream). Patch test preparations differed with regard to sensitivity (88.5-98.1%) and specificity (37.5-87.5%) against the ROAT result as external criterion. ROAT concentrations and the reaction strength in patch testing were inversely correlated (Kendall's tau-b: 0.69), both indicating the existence of different degrees of susceptibility. CONCLUSION: To protect 90% (50%) of people sensitized, the use concentration should be in the range of 0.009-0.027% (0.18-0.34%), depending on the product type. Taking into account these results, excessive concentrations should be avoided, as this would continue to sensitize people. Close monitoring is indispensable to prove the efficacy of any recommendations aiming to prevent induction.

The European baseline series in 10 European Countries, 2005/2006--results of the European Surveillance System on Contact Allergies (ESSCA).

BACKGROUND: Continual surveillance based on patch test results has proved useful for the identification of contact allergy. OBJECTIVES: To provide a current view on the spectrum of contact allergy to important sensitizers across Europe. PATIENTS/METHODS: Clinical and patch test data of 19 793 patients patch tested in 2005/2006 in the 31 participating departments from 10 European countries (the European Surveillance System on Contact Allergies' (ESSCA) www.essca-dc.org) were descriptively analysed, aggregated to four European regions. RESULTS: Nickel sulfate remains the most common allergen with standardized prevalences ranging from 19.7% (central Europe) to 24.4% (southern Europe). While a number of allergens shows limited variation across the four regions, such as Myroxylon pereirae (5.3-6.8%), cobalt chloride (6.2-8.8%) or thiuram mix (1.7-2.4%), the differences observed with other allergens may hint on underlying differences in exposures, for example: dichromate 2.4% in the UK (west) versus 4.5-5.9% in the remaining EU regions, methylchloroisothiazolinone/methylisothiazolinone 4.1% in the South versus 2.1-2.7% in the remaining regions. CONCLUSIONS: Notwithstanding residual methodological variation (affecting at least some 'difficult' allergens) tackled by ongoing efforts for standardization, a comparative analysis as presented provides (i) a broad overview on contact allergy frequencies and (ii) interesting starting points for further, in-depth investigation.

A comparison of mycophenolate mofetil with ciclosporine for the treatment of chronic plaque-type psoriasis.

AIMS: To compare the efficacy of ciclosporine (CsA) versus mycophenolate mofetil (MMF) in psoriasis, a randomized trial was conducted. METHODS: A prospective multicenter randomized open-label clinical trial was performed to compare two parallel groups of patients with chronic plaque psoriasis undergoing different treatments. Therefore, a total of 54 patients with psoriasis were randomly assigned to treatment with either CsA (2.5 mg/kg body weight) or MMF (2 g daily) for 12 weeks, and the drug doses were adjusted according to response. The psoriasis area and severity index (PASI) was used to assess the clinical severity of psoriasis. The primary outcome of this trial was the time to disease relapse. Safety, PASI scores and psoriasis disability index (PDI) were assessed as secondary outcome. RESULTS: There was no difference in time to disease relapse between the two groups. After 12 weeks of treatment, the mean PASI score (+/-SD) decreased from 24.6 +/- 11.1 to 6.6 +/- 7.3 in the CsA group (n = 27) and from 22.4 +/- 9.2 to 10.6 +/- 6.7 in the MMF group (n = 27; p = 0.02). The side effects, time to remission and PDI were similar in both groups. CONCLUSIONS: After 12 weeks, CsA demonstrated a significantly superior efficacy in psoriasis compared to MMF.

Chromated metal products may be hazardous to patients with chromate allergy.

BACKGROUND: Hidden allergen exposure may contribute to persistence and relapse of chromate dermatitis. According to case reports, chromated metal products, such as screws, fittings, etc., may be relevant allergen sources for patients sensitized to chromate. OBJECTIVES: To examine concomitant patch test reactivity to potassium dichromate 0.5% petrolatum (pet.) and three different types of chromated metal rings. PATIENTS/METHODS: Patients with proven or suspected chromate allergy were patch tested with potassium dichromate 0.5% pet. and three different types of chromated metal rings (yellow, olive, and black). Hexavalent chromium Cr(VI) release from the patch tested rings was chemically analysed. RESULTS: Ninety-five patients were tested: 49/95 (52%) reacted to potassium dichromate and 25/95 (26%) reacted to black chromated rings. Reactions to chromated rings exclusively occurred in patients reacting to potassium dichromate. Of 20 patients with a strong reaction to potassium dichromate, 14 reacted to black chromated rings. These were shown to have a high Cr(VI) release. Only two patients reacted to the other chromated rings, which had a very low Cr(VI) release. CONCLUSIONS: Handling chromated metal products must be regarded a hazard to chromate-sensitive patients, in particular those with a strong sensitization.