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The development of inflammatory process in the skin has proven to be primarily associated with the immune system defects, in particular T-lymphocytes: the Th2 response predominates during the acute phase of the disease, when Th2 cells are stimulated with the subsequent hyperproduction of IgE; during the chronic phase, the Th2- shifts to Th1-immune response. At the same time, a significant amount of pro-inflammatory cytokines IL-4, IL-5, IL-13, IL-31 and IFN-γ move into this process. In addition, it is known that skin reactions can be induced not only by food allergens, but also by other allergens (house dust mites, Staphylococcus aureus enterotoxins, mold fungi). The prevalence of atopic dermatitis among the children’s population is up to 20%, while half of the children have skin lesions characterized by a severe long-term course, which violates their quality of life. The main goal of external therapy of dermatoses is to achieve control over subjective symptoms (especially skin itching), as well as regression of inflammatory manifestations with subsequent persistent remission of the allergic process. Local therapy of manifestations of atopic dermatitis is based on the adequate use of various external forms, as well as means in accordance with the inflammatory manifestations and localization of the inflammatory process. The article describes clinical cases of treatment of atopic dermatitis with various variants of its course using methylprednisolone aceponate cream with ceramides, emollient agents. It has been shown that the combined use of topical corticosteroids and emollients contributes to a rapid reduction of inflammation, dry skin and itching. The absence of toxic and side effects on this type of therapy in children with high treatment efficiency is emphasized.

The results of clinical monitoring of the effectiveness and safety of therapy in adult patients with atopic dermatitis using various dosage forms of methylprednisolone aceponate are presented. The rationality of differentiated prescription of dosage forms of methylprednisolone aceponate in the localization of skin manifestation in the problem areas, on the skin of the torso and limbs, and according to the clinical manifestations is shown. The safety of the drug methylprednisolone aceponate in the treatment of patients with atopic dermatitis, the absence of side effects in the treatment at the specified time was confirmed.

Modern external therapy of dermatoses is aimed at controlling the subjective symptoms, the dynamics of inflammatory manifestations, the achievement and duration of remission. The step-by-step approach to the treatment of dermatoses in children and adults is based on the adequate use of various external forms and means according to the inflammatory manifestations and localization of the inflammatory process. The article describes clinical cases of treatment of atopic dermatitis in patients aged 8 and 11, and contact allergic dermatitis in a 15-year-old adolescent using methylprednisolone aceponate cream with ceramides in its base, tacrolimus ointment and emollients. High efficacy and safety of anti-inflammatory drugs for external use have been shown. Clinical examples have proven that the combined use of topical corticosteroids and emollients contributes to a rapid reduction of skin dryness and itching, as well as the intensity of inflammation. The possibility of combining methylprednisolone aceponate cream with ceramides in the base once a day and emollients with physiological lipids increases the effectiveness of therapy and reduces the risks of side effects when using topical corticosteroids in children.

Atopic dermatitis (AD) is one of the most common inflammatory diseases of childhood, and it is the first one in gradual development of allergic diseases, also known as «atopic march». Sensitization establishment during the AD uncontrolled course is associated with the high risk of developing of serious allergic pathologies, increase in the severity of the disease course, and patients’ quality of life reduction. Thereby, it is crucial to achieve quick jugulation of the inflammatory process in case of severe AD with early onset of disease. This article shows modern therapeutic approaches to disease control in children.

Local glucocorticoids (GCs) are the gold standard of anti-inflammatory topical therapy. The description of the main pharmaceutics properties and classification of local GCs, as well as its indications and contradictions are presented in the article. This article also provides fundamentals for application of local GCs which should be implemented for effective and safe use of these drugs in children. The problems of steroid-phobia (one of the reasons of the wrong and untimely administration of local GCs) are discussed. Advantages of 0.1% methylprednisolone aceponate (new generation GCs) use are discussed. This medication has optimal efficiency/safety ratio and unique bioactivation pathway that enables its effective administration in management of various dermatitis in children from 4 months of age. Results of different comparative and double blind placebo-controlled clinical trials of 0.1% methylprednisolone aceponate administration are discussed in this article. High efficiency and safety of this medication are noted. The use of modern local GCs at the first signs of skin inflammatory changes allows to relieve aggravation quickly and achieve remission of the disease.

The article considers the present-day idea of the etiopathogenesis of atopic dermatitis in children, which forms, from the pediatrician’s point of view, basis for decision making on effective modern therapeutic and preventive measures. Due attention is given to the description of highly effective topical glucocorticosteroids, which allows to gain control over the disease within a short time. Among all the topical corticosteroids of methylprednisolone aceponate 0.1%, local glucocorticosteroid can be used in children aged 4 months and older and has an optimal therapeutic index, safe, which is proved in the randomized trials. The article states the principles of management of sick children with atopic dermatitis, taking into account a wide range of comorbid conditions and diseases.

In the review article the basic problems of children’s health of young age are considered deficiency of vitamins and minerals at breastfeeding, complexity of skin care, allergies, acute respiratory viral infections. Attention is paid to hypovitaminosis and nipple cracks in mothers during lactation, as well as to the necessity of vitamin-mineral complexes subsidizing and mammary gland skin care during this period. Proper care for a child of early age is a guarantee of his health and harmonious development. Paediatricians should promote maternal literacy in modern methods of child care, disease prevention and treatment.

The article describes the main characteristics of local glucocorticosteroids (GCS) which are the «gold standard» for external therapy of atopic dermatitis allowing to achieve control over the disease quickly and effectively. Methylprednisolone aceponate 0.1% — non-fluorinated local GCS, the drug with the most favourable therapeutic index, the efficacy and safety of which has been demonstrated in numerous randomized trials — is the optimal therapeutic option in the treatment of AtD in children from 4 months.

The goals of the topical treatment of patients suffering from atopic dermatitis are suppression of the inflammatory reaction in the skin, elimination of itching, and recovery of the damaged protective lipid barrier of the epidermis. In this connection, topical glucocorticosteroids and skin moisturizers are used in the therapy of patients suffering from atopic dermatitis. Methylprednisolone aceponate (MPA, Advantan) being a topical glucocorticosteroid is characterized by high efficacy and safety. MPA is marked by the fast development of the therapeutic effect. This drug can be used for children older than 4 months and can be applied once a day. The availability of four dosage forms of MPA (emulsion, cream, ointment and fatty ointment) enables physicians to select a therapy with the use of this drug depending on the stage and localization of the skin lesion. Dexpanthenol (Bepanthen) being a tissue repair stimulator moisturizes the skin, protects the skin against an irritant effect, and restores the protective lipid barrier of the epidermis. The use of a combination of MPA being a topical glucocorticosteroid and dexpanthenol being a tissue repair stimulator can enhance the efficacy of the treatment of patients suffering from atopic dermatitis.

Lupus erythematosus tumidus is a rare skin form of lupus erythematosus. About 250 cases of lupus erythematosus tumidus have been described in the world by now. A specific clinical sign of this dermatosis is the appearance of annular or arcuate urticaria-like rash. As a rule, the appearance of the rash is preceded by ultraviolet irradiation. The administration of glucocorticosteroid drugs of local action belonging to classes of potent and very potent steroids is the first-line therapy for lupus erythematosus tumidus. The authors describe a case of the successful treatment of lupus erythematosus tumidus with methylprednisolone aceponate (Advantan ointment) in a female patient aged 56.

The article presents contemporary data on the peculiarities of etiology and pathogenesis of chronic itching dermatosis in children. We provide classification of various itching forms and pathophysiological mechanism of the development thereof underlying chronic skin disorders. We describe results of clinical studies of effectiveness and safety of methylprednisolone aceponate for treating itching dermatosis in children.

Infant's skin is very sensitive and susceptible to irritants and allergens. Combined with precipitating factors, genetic predisposition plays the key role. Chronic skin inflammation, or atopic dermatitis, is one of the most common pathologies which hinders and limits every day life of the baby and its parents. In the therapy of atopic dermatitis the focus should be on timely and adequate skin care aimed at reducing irritation, preserving the integrity of the child's skin and preventing complications, thereby improving the quality of life.

The article tells about the basic principles of local treatment of allergodermathosis in children and medicines used in the acute and remission stages; there is data on the efficacy and safety of the medicines.

The article is dedicated to the issues of external therapy of atopic dermatitis in children. Atopic dermatitis is a chronic allergic inflammatory skin disease; in most cases, it is the first manifestation of atopic march. Timely and adequate pathogenetic external therapy of this disease using topical glucocorticosteroids (TGCSs) helps to quickly and effectively terminate symptoms of the disease and allergic inflammation of the skin. Steroid phobia, which is prevalent among parents of the patients, reduced adherence to the TGCS therapy. The authors analyzed results of the original studies of effectiveness and safety of TGCSs, present general recommendations on TGCS use in children with due regard to morphofunctional peculiarities of children’s skin and clinical‑pharmacological description of the TGCSs featuring the most favorable therapeutic index of 0.1% methylprednisolone aceponate. Methylprednisolone aceponate available in 4 pharmaceutical forms is the optimal drug of choice for atopic dermatitis in children over 4 months of age.

The crystal structures of methylprednisolone aceponate were determined by X-ray diffraction analysis at temperatures 90 K and 150 K: space group P 2 1 2 1 2 1 , a = 14.8592(2), b = 19.6844(5), c = 26.1626(4) Å, Z = 12; R = 0.0598 (T = 90 K); space group P 2 1 2 1 2 1 , a = 6.57348(14), b = 14.8295(3), c = 26.2214(5) Å, Z = 4; R = 0.0518 (T = 150 K). Features of structural changes in the phase transition were revealed. The abrupt change in the unit cell parameters in the phase transition was shown by low-temperature X-ray powder. The methods of degree of invariance of crystal electron density and molecular Voronoi−Dirichlet polyhedra were used for the analysis of polymorphism in methylprednisolone aceponate. The atomic structure at 90 K have a translational pseudosymmetry of electron density η = 0.329(1). The decrease of number of intermolecular contacts in the high-temperature modification due to rupture of intermolecular non-valence contacts C/O was observed. [ABSTRACT FROM AUTHOR]

The article reviews scientific literature and provides own results of phased application of methylprednisolone aceponate (Advantan, BAYER) and Dardia products in the multimodal treatment of children with atopic dermatitis. The effectiveness and safety of the treatment are demonstrated.

In the present work, temperature dependence of heat capacity of methylprednisolone aceponate has been measured for the first time over the range from 7 K to 346 K by precision adiabatic vacuum calorimetry. Based on the experimental results, the thermodynamic functions of the methylprednisolone aceponate, namely, the heat capacity, enthalpy H °( T )− H °(0), entropy S °( T )− S °(0) and Gibbs function G °( T )− H °(0) have been determined for the range from T /K → 0–333. The enthalpy of combustion (−14304.4 ± 9.1) kJ·mol −1 of the methylprednisolone aceponate was determined for the first time using high-precision combustion calorimeter. The standard molar enthalpy of formation in the crystalline state (−1465.3 ± 9.8) kJ·mol −1 of compound at 298.15 K was derived from the combustion experiments. Using a combination of the adiabatic and combustion calorimetry results the thermodynamic functions of formation of the folic acid dihydrate at T = 298.15 K and p = 0.1 MPa have been calculated. [ABSTRACT FROM AUTHOR]

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Objective: To assess the efficacy of methylprednisolone aceponate 0.1% (MPA 0.1%) in female genital lichen sclerosus (GLS) and efficacy of MPA, tacrolimus or emollient for prevention of flares. Methods: A single-center, retrospective study was conducted. At baseline, female patients with relapsing GLS ( n = 46) were treated with MPA 0.1% applied once daily for 8 weeks. Visual Analog Scale (VAS) score for vulvar pruritus and Investigator's Global Assessment (IGA) score were recorded at baseline, weeks 8 and 20. At week 8, patients responsive to treatment ( n = 38) were further treated with MPA 0.1% twice weekly ( n = 15), tacrolimus once daily ( n = 13) or topical emollient once daily ( n = 10), as maintenance therapy until week 20. Result: Both VAS and IGA median score was significantly decreased from baseline to week 8 ( p = 0.000). At week 20, both median VAS and IGA scores differed significantly between patients treated with emollient and patients treated with MPA 0.1% ( p = 0.000) and patients treated with emollient and patients treated with tacrolimus ( p = 0.000); patients treated with MPA 0.1% presented no significant difference in either median VAS score ( p = 0.032) or median IGA score ( p = 0.636) at week 20 compared to patients treated with tacrolimus. Conclusions: MPA 0.1% is effective in relapsing female GLS. MPA 0.1% and tacrolimus have equal efficacy in preventing relapses. [ABSTRACT FROM AUTHOR]

BACKGROUND: Pruritus can be defined as an unpleasant cutaneous sensation associated with the immediate desire to scratch. In particular external intimate zone could be hit by pruritus genitalis because of several reasons (bacterial infection, fungal infection, stress, bad intimate behavior, synthetic intimate clothes). AIM: The aim of the study was to compare the efficacy of Dermoxen® Lenitiva cream versus a methylprednisolone aceponate 0.1% based cream in treating pruritus of the external genitalia. PATIENTS AND METHODS: Independent, randomized, double-blind, controlled trial in two University affiliated Italian Hospitals. 80 women, affected by aspecific pruritus genitalis with negative vaginal swab for bacterial or fungal infections or other pathogenic causes of itching, were selected and blindly treated by Dermoxen® Lenitiva cream or methylprednisolone aceponate 0.1% based cream. The main outcome measures were: the reduction of sensation of pruritus, evaluated by a visual analog scale (VAS) pain score, and improvement of intimate wellness sensation, and comfort during sexual intercourse, frequency and severity of adverse reactions. RESULTS: Significant reduction of itching sensation was verified for each treatment. CONCLUSIONS: Based on our results, DermoXen ® Lenitiva vaginal cream showed efficacy so as methylprednisolone aceponate 0.1% based cream for itching treatment on external female genitalia and improved intimate comfort and comfort in sexual intercourse. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a chronic, recurring, pruritic, inflammatory skin condition which has its onset in early childhood in most cases. A stepped approach to therapy, starting with emollients and adding first mild and then more potent topical medications is recommended. For more than 50 years, topical corticosteroids (TCs) have been the gold standard in AD therapy. Increasingly potent TCs have tended to come with increasing risk of adverse events, however. Calculating the benefit/risk ratio [or therapeutic index (TIX)] for TCs when treating children and infants is more challenging in this population. Not only does their increased surface area to volume ratio as a result of their small size mean that they are likely to absorb a greater proportion of any active agent applied to their skin, but drug metabolism is slower than in adults and the systemic effects of corticosteroids are more pronounced (in particular reduction of serum cortisol levels through suppression of the hypothalamic-pituitary-adrenal axis). Unlike traditional TCs, topical calcineurin inhibitors are not associated with the systemic effects and have shown good efficacy in treating AD in children. Parental/Carer concerns about their long-term use can limit their acceptance for treatment in the paediatric population, however. Modifications to the structure of fourth generation corticosteroids mean that increased potency is not accompanied by increased risk of adverse events and hence they have an improved TIX. Methylprednisolone aceponate is a potent fourth generation corticosteroid which has demonstrated efficacy and safety in acute and maintenance programmes in infants and children. It is licenced for once-daily use, and is available in four formulations - ointment, fatty ointment, cream and milk, which combine with its improved TIX to meet the needs of young patients and their carers. [ABSTRACT FROM AUTHOR]

Two cases of segmental lichen aureus with a response to topical 0.1% methylprednisolone aceponate ointment are reported. A 9-year-old child and a 23-year-old man showed complete resolution of their lesions following treatment with the latter after 7 months and 4 months, respectively. Lichen aureus is a rare form of the pigmented purpuric dermatoses characterized by golden-brown and lichenoid macules and papules, most often on the lower extremities. Segmental presentations have seldom been described. Histology showed a lichenoid infiltrate with extravasation of red blood cells and haemosiderin deposition. The aetiology is unclear and treatment is disappointing. We report an uncommon segmental presentation of lichen aureus with resolution of the lesions after treatment with a topical corticosteroid. [ABSTRACT FROM AUTHOR]

Abstract: In drug development, it has been noticed that some drug compounds, especially esters, are unstable in serum samples ex vivo. This can lead to a substantial underestimation of the actual drug concentration. The rat and the dog, representing a rodent and non-rodent species, respectively, are widely used in preclinical studies. We studied the degradation of three structurally different drug esters in rat and dog serum. Moreover, the efficiency of selected enzyme inhibitors to prevent these degradations was investigated. Furthermore, we found indications of the identity of the drug-specific esterases by means of their inhibitor sensitivity as well as by protein purification and identification. The studied drugs were sagopilone, drospirenone, and methylprednisolone aceponate (MPA) all of which are used in (pre-)clinical drug development. The sagopilone-cleaving esterases in rat serum were inhibited by serine hydrolase inhibitors. We partly purified these esterases resulting in an activity yield of 5% and a purification factor of 472. Using matrix-assisted laser desorption ionization (MALDI)–time of flight (TOF)–mass spectrometry (MS), the rat carboxylesterase isoenzyme ES-1 was identified in these fractions, thus pointing to its involvement in sagopilone cleavage. Drospirenone cleavage in rat serum was effected by butyrylcholinesterase (BChE) and paraoxonase 1 (PON1) as we deduced from the high efficacy of certain serine hydrolase and metallohydrolase inhibitors, respectively. Likewise, some inhibition characteristics implied that MPA was cleaved in rat serum by BChE and serine proteases. Partial purification of the MPA-specific esterases resulted in activity yields of 1–2%, exhibiting up to 10,000-fold purification. In dog serum, we found that sagopilone was not degraded which was in contrast to MPA and drospirenone. MPA degradation was mainly prevented by serine hydrolase inhibitors. We used a three-step purification to isolate the esterases cleaving MPA. This procedure resulted in an activity yield of 12% and 645-fold purification. By protein identification using liquid chromatography (LC)–electrospray ionization (ESI)–MS, we identified α2-macroglobulin (α2M) in the active fractions. We therefore assumed that serine hydrolases, probably butyrylcholinesterase, known to form esteratically active complexes with α2M, were responsible for MPA cleavage. In contrast, PON1 was assumed to be involved in drospirenone cleavage due to the high efficiency of metallohydrolase inhibitors. This indication was supported by the presence of PON1 in drospirenone-cleaving fractions as we found by affinity chromatography and Western immunoblotting for isolation and detection of PON1, respectively. The identity of the assumed cleaving enzymes remains, however, to be further studied. The inhibitors we found can serve as a tool for stabilizing drug ester compounds in biological samples ex vivo. [Copyright &y& Elsevier]

Background: Seborrhoeic dermatitis is a common, chronic, papulosquamous dermatosis. Treatment of seborrhoeic dermatitis includes topical treatments such as corticosteroids, antifungals, metronidazole and pimecrolimus. Objective: This study aimed to compare and contrast the efficacy and tolerability of pimecrolimus cream 1%, methylprednisolone aceponate 0.1% cream and metronidazole 0.75% gel topical treatments in the treatment of facial seborrhoeic dermatitis. Methods: The study included a total of 64 (32 males and 32 females) consecutive patients with facial seborrhoeic dermatitis. Patients were randomized into three equal groups. One group applied pimecrolimus 1% cream, another group applied methylprednisolone aceponate 0.1% cream, and the third group applied metronidazole 0.75% gel to their facial lesions twice daily for 8 weeks. Assessment of the disease severity was performed at baseline and at weeks 2, 4, and 8. Clinical measures assessed were erythema, scaling and pruritus, which were evaluated using a four-point scale (0–3). Results: Of the 64 patients, 17 (80%) in the metronidazole group, 21 (100%) in the pimecrolimus group and 22 (100%) in the methylprednisolone aceponate group completed the study. Four patients in the metronidazole group left the study. All of the therapeutic agents were found to be effective; however, the efficacy of pimecrolimus was higher than those of metronidazole and methylprednisolone ( p < 0.05). When side effects associated with pimecrolimus and metronidazole were compared, the latter was found to be associated with more side effects ( p < 0.05). Conclusions: We suggest pimecrolimus to be a therapeutic option for seborrhoeic dermatitis cases that show an unfavourable response to methylprednisolone aceponate. [ABSTRACT FROM AUTHOR]

Background The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of active AD, but their long-term efficacy and potential to reduce or prevent relapses have only partially been addressed. Objectives To investigate long-term management (16 weeks) of AD with methylprednisolone aceponate (MPA) 0·1% cream twice weekly in addition to an emollient (Advabase®) after stabilization of an acute severe or very severe flare of AD with MPA cream. Methods Patients ≥ 12 years of age with a ≥ 2-year history of moderate to severe AD were eligible for this multicentre, randomized, double-blind, controlled study if they presented with an acute flare of severe or very severe AD [Investigator’s Global Assessment (IGA) score ≥ 4]. After successful treatment of the flare in an acute phase (AP), patients received either MPA twice weekly plus emollient or emollient alone over a 16-week maintenance phase (MP). The primary study endpoint was time to relapse of AD. Secondary endpoints included relapse rate and disease status, the patient’s assessment of intensity of itch, the Eczema Area and Severity Index, the IGA score, affected body surface area, Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI), patient’s and investigator’s global assessment of response and patient’s assessment of quality of sleep. Results Two hundred and forty-nine patients entered the AP and 221 continued into the MP. Time to relapse was longer in the MPA group than in the emollient group. The probability of remaining free from relapse after 16 weeks was 87·1% in the MPA group compared with 65·8% for the emollient. Patients treated with MPA twice weekly had a 3·5-fold lower risk of experiencing a relapse than patients treated with emollient alone (hazard ratio 3·5, 95% confidence interval 1·9–6·4; P < 0·0001). MPA was also superior to emollient for all other efficacy endpoints. Therapy with both treatments was well tolerated. Conclusions MPA twice weekly plus an emollient provides an effective maintenance treatment regimen to control AD. Once stabilized, treatment with MPA significantly reduces the risk of relapse and the intensity of itching, and improves the overall patient status. [ABSTRACT FROM AUTHOR]

Background: Topical glucocorticosteroids are the gold standard in treatment of atopic dermatitis (AD). Recently, topical calcineurin inhibitors have been developed for treatment of this condition. This study compared efficacy and safety of 0.1% methylprednisolone aceponate (MPA) ointment with 0.03% tacrolimus ointment for 3 weeks, in children and adolescents with severe to very severe flare of AD. Methods: The primary end point was treatment success, defined as a score of ‘clear’ or ‘almost clear’ in the static Investigator's Global Assessment (IGA) score. Secondary end points were the percentage change in the Eczema Area and Severity Index (EASI) and patients’ assessment of itch and sleep, Children's Dermatology Life Quality Index, patient's assessment of global response, affected Body Surface Area and medication costs. Results: 265 patients were randomized to either MPA ( n = 129) or tacrolimus ( n = 136) treatment, 257 patients completed the study. Methylprednisolone aceponate 0.1% ointment once daily provided rapid and relevant clinical benefit. Tacrolimus 0.03% ointment twice daily was equally effective with regard to success rate. Methylprednisolone aceponate was superior to tacrolimus for EASI, itch and sleep. Both treatments were well tolerated. Drug-related adverse events were only observed in the tacrolimus group. Medication costs were significantly lower for MPA. Conclusions: While both treatment groups showed similar efficacy results regarding treatment success (IGA), significant advantages were observed for EASI, itch and sleep with MPA 0.1%. These advantages and the significantly lower treatment costs highlight the benefits of MPA treatment, underlining its first-line role in treatment of children and adolescents with severe AD. [ABSTRACT FROM AUTHOR]

Methylprednisolone aceponate (MPA) has been shown to provide rapid, reliable and highly effective treatment of eczematous disorders, with an efficacy comparable to that of most reference topical corticosteroids. It also has excellent local and systemic tolerability. MPA is effective in the treatment of facial and scalp eczema and sunburn and has shown promising results in the treatment of psoriasis. Its rapid efficacy and lack of undesirable local and/or systemic side effects make MPA particularly suitable for use in children and infants. The wide range of formulations (0.1%) of MPA, including cream, ointment, fatty ointment, milk and solution, enable treatment to be tailored to the individual patient. In addition, MPA has the advantage of once-daily application compared with twice-daily treatment for other topical corticosteroids, thereby improving patient safety and promoting patient compliance but without compromising efficacy. [ABSTRACT FROM AUTHOR]