Contact haptens in emollients marketed in two European countries (Poland and Spain).

INTRODUCTION AND OBJECTIVES: Atopic dermatitis (AD) is the most common skin disease among pediatric patients, which affects up to 20% of children worldwide. Characterized by pruritus and eczema, it is also associated with improper skin barrier function and allergen sensitization. Here, we aimed to assess the presence of haptens in emollients marketed in two European countries: in Poland and Spain, as, firstly, these products are considered to be AD's basic therapy, and, secondly, frequent application of potent sensitizers on atopic skin may result in contact dermatitis. MATERIALS AND METHODS: We systematically searched for moisturizers explicitly described as "Atopic skin care" products in the most frequently visited online pharmacies in Poland and Spain. Subsequently, we created a database of all products and compared their composition with 139 contact haptens listed in the European Baseline Series (EBS), Fragrance and Cosmetic Series. RESULTS: As of December 2018, our list comprised 159 and 111 emollients available on the Polish and Spanish markets, respectively. There were no ingredients listed in 28 (17.5%) products in Poland and 24 (21.6%) in Spain. Only 23 (17.5%) and 13 (14.8%) products were hapten free. The pattern of most common haptens was similar in both countries, including phenoxyethanol, tocopherol and tocopheryl acetate, undefined parfum in Poland and tocopherol, phenoxyethanol, tocopheryl acetate and undefined parfum in Spain. CONCLUSIONS: This study shows that a vast majority of products taken into consideration contain at least one potential contact hapten. These findings indicate a need for patient education about potentially allergenic ingredients and stronger cooperation between academia and cosmetic manufacturers.

Moisturizers: A Comparison Based on Allergens and Economic Value.

BACKGROUND: The economic burden of cosmetics, such as moisturizers, has been increasing. Despite the high price of some market moisturizers, there have been no studies evaluating the allergenicity of these products. OBJECTIVE: The aim of this study was to evaluate the potential allergens within moisturizers based on economic value, by analyzing the substances found in moisturizers available online at the largest drugstore chain-CVS Health (CVS Health, Woonsocket, RI). METHODS: In this cross-sectional study, ingredients found in 50 expensive and 50 inexpensive moisturizers were matched with sensitizers within the Core Allergen Series published by the American Contact Dermatitis Society and the North American Contact Dermatitis Group. Student t test was used to compare the mean number of allergens present in each group. A χ test or Fisher exact test, where necessary, was used to compare the rates of specific allergen groups between the expensive and inexpensive products. RESULTS: Twenty-six allergenic substances were present overall in the 100 total products surveyed. The expensive moisturizers averaged significantly more allergens per product (8.28 vs 5.60, P = 0.003) than the inexpensive products. CONCLUSIONS: The sensitizing potential of expensive moisturizers may be higher than that of inexpensive moisturizers. Physicians may counsel cosmetic-induced allergic contact dermatitis (ACD) patients that monetary value is not a suitable proxy for evaluating the risk of ACD.

Photodegradation of (-)-epigallocatechin-3-gallate in topical cream formulations and its photostabilization.

The aim of the study was to examine the photostability of the major catechin of green tea, (-)-epigallocatechin-3-gallate (EGCG), which possesses important antioxidant and skin photoprotective properties. In order to simulate realistic conditions of use of topical preparations, the photolysis studies were performed in model creams (oil-in-water emulsions) containing 1% (w/w) EGCG and exposed to a solar simulator at an irradiance corresponding to natural sunlight. The extent of photodegradation was measured by HPLC-UV and HPLC-ESI-MS. EGCG was found to decompose by 68.9±2.3%, after 1h irradiation. Addition of the coantioxidants, vitamin E or butylated hydroxytoluene to the emulsion formulation, significantly enhanced the photolability of the catechin, the EGCG loss reached 85.7±1.3% and 80.5±1.4%, respectively. On the other hand, inclusion of the UVB (290-320nm) filter, ethylhexyl methoxycinnamate in the cream produced a small but significant reduction of EGCG photodegradation to 61.0±2.9%, while the UVA (320-400nm) filter, butyl methoxydibenzoylmethane was ineffective (EGCG degradation, 67.8±1.5%). A more marked decrease in the light-induced decomposition of EGCG to 51.6±2.7% was achieved, under the same conditions, using the water-soluble UVB filter, benzophenone-4 (BP-4). This effect was concentration dependent, maximal EGCG photostabilization (catechin loss, 29.4±2.2%) was attained in the presence of 2.1% (w/w) BP-4. Therefore, BP-4 represents a useful additive to improve the light stability of EGCG in topical formulations for skin photoprotection.

Evaluating lotion transfer to skin from feminine protection products.

BACKGROUND/PURPOSE: Adding lotions or emollients to the surface of a variety of paper products improves overall consumer comfort. Techniques to measure lotion transfer to skin are needed. METHODS: Two approaches were compared to assess lotion transfer from impregnated feminine pads: (1) pad application to the popliteal fosssa, an adaptation of the previously described 'behind-the-knee (BTK)' test model, and (2) a clinical in-use study in which pads were worn in the usual manner. In both approaches, dressings attached to the skin were used to absorb lotion transferred from the pad. Lotion transfer was first evaluated after 3 h in both protocols, and then after either 6 h (BTK method) or after and 24 h (clinical use test). RESULTS: In the BTK model, lotion transfer was a function of both the total amount of lotion contained on the topsheet and the type of absorbent material in the core of the pad. Pads containing absorbent gelling material transferred lotion more effectively than pads containing cellulose absorbent cores. In the in-use clinical study, the results were directionally similar, but statistical significance was not reached. CONCLUSIONS: An adaptation of the BTK test method provides an effective means of evaluating the transfer of lotion formulations from feminine protection pads.

Levels of nickel and other potentially allergenic metals in Ni-tested commercial body creams.

It is extensively well-known that Ni and other metals occurring as impurities in cosmetic products might give rise to contact dermatitis in subjects with pre-existing allergy. The present study on the content of 13 metals (Cd, Co, Cr, Cu, Hg, Ir, Mn, Ni, Pb, Pd, Pt, Rh, and V) in moisturizing creams, labelled as "Ni-tested" (i.e., Ni content <100 ng g(-1)) and available on the Italian market, provides a basis for assessing their safety for consumers. Quantification of metals was performed by sector field inductively coupled plasma mass spectrometry after microwave-assisted acid digestion of products. The developed method had limits of quantification less than 0.8 ng g(-1) for all the elements; recovery was in the interval 88% (Cd, Co) to 110% (Hg), and precision was always under 7%. Nickel was present in all the products with levels between 17.5 and 153 ng g(-1); three skin creams were slightly above the concentration reported on the label. The other elements were at levels below 1 microg g(-1). The highest concentrations, in ng g(-1), of Co, Cr, Cu, and Mn were 222, 303, 51.2, and 59.9, respectively. Mean Cd, Pb, and V were below 5 ng g(-1), while Hg was absent in all the samples. Among the new emergent allergens, Ir and Rh were in traces or even undetectable, while Pt had levels of 2.65 and 6.28 ng g(-1) in two creams and Pd was equal to 1.07 ng g(-1) in one product. The overall results are below the sensitizing limit proposed for consumer products and, thus, probably have no significant toxicological effects. Nevertheless, some creams presented amounts of Co and Cr comparable to those of Ni and therefore they have to be monitored in consideration of their cross-reactivity as well.

Emollients in a propanol-based hand rub can significantly decrease irritant contact dermatitis.

The objective of this study is to determine the effect of emollients in a propanol-based hand rub on skin dryness and erythema. In this prospective, randomized, controlled, double-blind trial, 35 subjects participated; of them approximately half were atopic (modified Erlanger atopy score > or =8). 2 propanol-based formulations were tested in a repeated open application test, 1 contained a mixture of emollients (0.81%, w/w). 2 aliquots of 0.7 ml of each formulation were applied twice per day over 2 weeks to the cubital fossa of each subject after random assignment of the preparations. Treatment areas were assessed before each application and 3 days postfinal application by visual inspection for erythema and dryness according to a standard scale. The sum score over all assessment time-points served as primary parameter. The mean sum score for erythema and dryness was significantly lower for the hand rub with emollients (0.8 +/- 2.4) in comparison with that for the hand rub without emollients (1.5 +/- 3.5; P = 0.022; Wilcoxon signed rank test). A comparison of the atopic and non-atopic subjects revealed no significant difference for any of the products (P > 0.05; Mann-Whitney U-test). It is concluded that the addition of emollients to a propanol-based hand rub can significantly decrease irritant contact dermatitis under frequent-use conditions.

Simultaneous determination of methylparaben, propylparaben, hydrocortisone acetate and its degradation products in a topical cream by RP-HPLC.

A novel reversed-phase high-performance liquid chromatographic method with UV spectrophotometric detection was developed and validated for the determination of compounds in topical cream. The method describes determination of active component hydrocortisone acetate (HCA), its degradation products hydrocortisone (HC) and cortisone acetate (occurring in formulation after long-term stability tests) and two preservatives presented in the cream-methylparaben and propylparaben, using dexamethasone as an internal standard. The chromatographic separation was performed on a 5 microm SUPELCO Discovery C18 125 x 4-mm ID column. The optimised mobile phase for separation of all the compounds consists of methanol, acetonitrile and water (15:27:58, v/v/v), with the analysis time less than 13 min. The method was applicable for routine analysis (assays and stability tests) of active compound HCA, preservatives and degradation products in pharmaceutical product--topical cream Hydrocortizone cream 1%.

A method for quantification of formaldehyde in the presence of formaldehyde donors in skin-care products.

Reliable and uncomplicated methods for detection of free formaldehyde in products preserved with formaldehyde donors are desirable to decrease the risk of allergic contact dermatitis. The aim of this study was to develop a method that could be used in clinics and workplaces for quantification of free formaldehyde in products preserved with formaldehyde donors. The method developed is named the closed container diffusion (CCD) method. Formaldehyde in a sample is allowed to evaporate in a closed container and react with 2,4-dinitrophenylhydrazine coated on a glass fibre filter. The hydrazone formed is analyzed with HPLC. The method was tested on 3 different formaldehyde donors, imidazolidinyl urea, diazolidinyl urea and 2-bromo-2-nitropropane-1,3-diol, using 4 different cream bases. The results obtained with this method accord, with those obtained with the official method within the European Union (EU). The method is sensitive enough for analysis of patients' products and for control of labelled amounts of formaldehyde in technical products without solvent extraction. As a result of our studies, we observed a risk of exceeding the labelling limit for free formaldehyde in cosmetic products when using the highest amount of diazolidinyl urea allowed within the EU.

A case of contact dermatitis due to impurities of cetyl alcohol.

A 29-year-old man being treated for itchy lesions on the amputation stump of the thigh became allergic to betamethasone valerate and gentamicin sulfate cream (Rinderon VG). Closed patch tests with all the ingredients of the cream revealed positive reactions to cetyl alcohol 30% to 5% pet. Gas chromatographic analysis of the cetyl alcohol in the cream base detected stearyl alcohol (C18), myristyl alcohol (C14) and lauryl alcohol (C12) in addition to the main component of cetyl alcohol (C16). Patch testing with 99% pure analytical reagent grade saturated alcohols (C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20) showed negative reactions. Thus, it is concluded that some minor impurities in cetyl alcohol not detected by gas chromatography might be the cause of this dermatitis.

Natural ingredients based cosmetics. Content of selected fragrance sensitizers.

In the present study, we have investigated 42 cosmetic products based on natural ingredients for content of 11 fragrance substances: geraniol, hydroxycitronellal, eugenol, isoeugenol, cinnamic aldehyde, cinnamic alcohol, alpha-amylcinnamic aldehyde, citral, coumarin, dihydrocoumarin and alpha-hexylcinnamic aldehyde. The study revealed that the 91% (20/22) of the natural ingredients based perfumes contained 0.027%-7.706% of 1 to 7 of the target fragrances. Between 1 and 5 of the chemically defined synthetic constituents of fragrance mix were found in 82% (18/22) of the perfumes. 35% (7/20) of the other cosmetic products (shampoos, creams, tonics, etc) were found to contain 0.0003-0.0820% of 1 to 3 of the target fragrances. Relatively high concentrations of hydroxycitronellal, coumarin, cinnamic alcohol and alpha-amyl cinnamic aldehyde were found in some of the investigated products. The detection of hydroxycitronellal and alpha-hexylcinnamic aldehyde in some of the products demonstrates that artificial fragrances, i.e., compounds not yet regarded as natural substances, may be present in products claimed to be based on natural ingredients.

[Thin layer chromatographic detection of emollients in gastric juice-resistant coatings. 2. The pharmaceutic technology and analysis of gastric juice-resistant dosage forms]. / Dünnschichtchromatografischer Nachweis von Weichmachern in magensaftresistenten Uberzügen. 2. Mitteilung: Uber pharmazeutisch-technologische und analytische Untersuchungen an magensaftresistenten Darreichungsformen.

Softeners in enteric coatings as phthalic acid esters, citric acid esters, tartaric acid esters, glycerine esters, alcohols or surfactants can be identified by thin layer chromatography. Normally they are extracted by ether out of a phosphate buffer solution of the coating. In exceptional cases, it is necessary to extract dry isolated enteric coatings with acetone/ethanol. As developing solvents butanol and methylene-chloride are recommended. To separate similar substances as glycerine-diacetate from glycerine-triacetate it can be necessary to evaluate the results in both developing solvents. Softeners had been isolated and identified from 9 examples of commercial drugs.