Administration Of Topical Corticosteroids Research Articles

Biologics for eosinophilic otitis media: a retrospective case study in a multidisciplinary center.

Eosinophilic otitis media (EOM) is a difficult-to-treat otitis media characterized by eosinophilic accumulation in the middle ear mucosa and effusion. It is refractory to conventional treatments and is strongly associated with asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The diagnostic criteria for EOM were established by IINO in 2011. With the recognition of type 2 inflammatory diseases, the gold standard of treatment is the systemic and topical administration of corticosteroids. Recently, several retrospective studies have demonstrated the efficacy of biologic treatments in EOM. We aimed to share our experience regarding the response of EOM after the use of biologics. This is a retrospective observational analysis including patients with refractory EOM treated with different biologics (benralizumab, omalizumab, mepolizumab, dupilumab) for concomitant severe asthma, urticaria and/or severe uncontrolled CRSwNP from 2011 to 2023. Treatment effectiveness in terms of EOM severity was measured using medical Global Evaluation of Treatment Effectiveness (GETE). We illustrated 4 clinical cases of uncontrolled comorbid EOM and demonstrated the complexity of multidisciplinary medical pathway with good response to biologics. We also observed that response to EOM and CRSwNP does not always follow that of asthma. The results of our small sample were consistent with those found in the literature and showed control of EOM with biologics. We need a larger multicentric sample and methodology to confirm these results and to compare the efficacy of different biologics.

Cushing's Syndrome and Topical Corticosteroids in Pediatrics: A Systematic Review

Introduction Despite the increasing number of pediatric cases of iatrogenic Cushing's syndrome (CS) due to topical corticosteroids, systematic reviews are lacking to provide comprehensive insights into the disease. This study aims to provide a systematic overview of the disease. Methods Relevant literature was identified using Google Scholar and PubMed. The search strategy was restricted to studies on human published in English. The inclusion criteria encompassed confirmed pediatric cases of iatrogenic CS induced by topical corticosteroids. Results The mean age of the cases was 38.8 months, with a female gender predominance (57.1%). Abnormalities in growth patterns were observed in approximately 75% of the cases. The most common clinical presentation was a "moon face" appearance (74.6%), followed by weight gain (55.5%). Clobetasol propionate was the most frequently used topical steroid (54%), followed by betamethasone types (35%). The mean duration of steroid use was 25.4 weeks. The primary indications for steroid use were dermatitis (47.6%), psoriasis (17.5%), and scabies (15.9%). Laboratory tests for adrenocorticotropic hormone and cortisol levels revealed low levels in 73% and 78% of cases, respectively. All cases had their initial steroid discontinued. Oral hydrocortisone was the primary replacement therapy (39.7%), followed by sulfur cream (12.7%). Fifty-one cases (81%) recovered from the disease. Partial recovery was observed in 2 cases (3.2%), while four cases (6.3%) did not survive. Conclusion A specialist should supervise topical corticosteroid administration, and parents need to be fully informed about the proper usage and potential side effects to avoid iatrogenic CS and other complications.

IDENTIFICATION AND TREATMENT OF ERYTHEMA MULTIFORME INDUCED BY ALLOPURINOL

Introduction: Allopurinol is a xanthine oxidase inhibitor and has become established as the drug of choice for preventing and treating chronic gout. Erythema multiforme (EM) is an immune-mediated reaction that involves the skin and sometimes the mucosa. Many cases of EM are caused by drugs, one of which is allopurinol. The purpose of the case study is to explain the identification of allopurinol as a predisposing factor for EM and how it is treated. Case. A 56-year-old woman came with complaints of scabs on her lips for 1 week ago, and had been treated with corticosteroid ointment for 3 days. Extraoral examination showed hemorrhagic crusts on the upper and lower lips with erosive surrounded by erythematous margins. On the extremity found a target lesion on the right hand. Based on the examination, the patient was diagnosed with Erythema Multiforme with a differential diagnosis of herpes labialis and herpes associated erythema multiforme. Case Management. The therapy in this case was giving antihistamines for 1 week, NaCl 0.9% compresses on the lips for 30 minutes 3 times a day, after 2 weeks of treatment added with the application of 1% hydrocortisone cream as an anti-inflammatory and petroleum jelly on the lips as a moisturizer. Conclusion. Identification of the etiology of this EM case was carried out through anamnesis and history of drugs consumed as well as administration of topical corticosteroids as anti-inflammatories and oral antihistamines to reduce allergic reactions.

Central Serous Chorioretinopathy in a 14-year-old atopic boy: a case report

BackgroundCorticosteroids are widely used in medicine. Few cases of central serous chorioretinopathy (CSC) have been reported following topical corticosteroid administration. We describe the first case of pediatric CSC related to topical corticosteroid administration.Case presentationA 14-year-old boy presented with decreased vision, pigment epithelial detachments, and serous retinal detachments in the right eye after starting treatment for atopic dermatitis with Betamethasone Valerate 0.1% topical ointment. His condition resolved 2 weeks after discontinuing the steroid and administering Bromfenac 0.9 mg/ml eyedrops.ConclusionsAlthough the pathogenesis of CSC is poorly understood, ophthalmologists should be informed about the potential link between CSC and topical corticosteroid treatment, and they should be aware that CSC might, albeit infrequently, affect children.

Efficacy of Topical Administration of Corticosteroids for the Management of Dry Eye Disease: Systematic Review and Meta-Analysis.

The efficacy of corticosteroids (CS) for dry eye disease (DED) has been investigated in the clinical setting. The present study investigated whether topical CS application improves the clinical outcome at last follow-up compared to the baseline. The present study was conducted according to the PRISMA 2020. All the randomized clinical trials (RCTs), which investigated the efficacy of corticosteroids in the management of DED, were accessed. In September 2022, the following databases were accessed: Pubmed, Web of Science, Google Scholar, and Embase. The following data were extracted at baseline and at last follow-up: Ocular Surface Disease Index (OSDI), tear breakup time test (TBUT), Schirmer I test (SIT), and corneal staining. Data from 425 patients were retrieved. A total of 69.4% (295 of 425 patients) were women. CS were effective to improve SIT (p = 0.02) and corneal staining (p = 0.003) at the last follow-up of 10.0 ± 15.3 weeks. TBUT was greater in the CS than in the control group at the last follow-up (p = 0.002). Concluding, topical CS administration led to an increase of SIT and a reduction of corneal staining at a mean of 10 weeks follow-up in patients with DED. Compared to a control group, topical CS administration evidenced greater values of TBUT. Altogether, a good safety profile was witnessed in DED patients receiving CS. However, different safety profiles of different CS formulations were not investigated due to a lack of quantitative data. The exact dosing frequency, duration of therapy, and favorable potency of the CS are still under investigation. Future randomized, controlled trials with larger sample sizes are warranted to provide higher-quality evidence to establish the role of CS in DED.

Effect of the topical administration of corticosteroids and tuberculin pre-sensitisation on the diagnosis of tuberculosis in goats

BackgroundCaprine tuberculosis (TB) is a zoonosis caused by members of the Mycobacterium tuberculosis complex (MTBC). Caprine TB control and eradication programmes have traditionally been based on intradermal tuberculin tests and slaughterhouse surveillance. However, this strategy has limitations in terms of sensitivity and specificity. Different factors may affect the performance of the TB diagnostic tests used in goats and, subsequently, the detection of TB-infected animals. In the present study, the effect of two of the factors that may affect the performance of the techniques used to diagnose TB in goats, the topical administration of corticosteroids and a recent pre-sensitisation with tuberculin, was analysed.MethodsThe animals (n = 151) were distributed into three groups: (1) a group topically treated with corticosteroids 48 h after intradermal tuberculin tests (n = 53); (2) a group pre-sensitised with bovine and avian purified protein derivatives (PPDs) 3 days before the intradermal tuberculin test used for TB diagnosis (n = 48); and (3) a control group (n = 50). All the animals were tested using single and comparative intradermal tuberculin (SIT and CIT, respectively) tests, an interferon-gamma release assay (IGRA) and a P22 ELISA.ResultsThe number of SIT test reactors was significantly lower in the group treated with corticosteroids when compared to the pre-sensitised (p < 0.001) and control (p = 0.036) groups. In contrast, pre-sensitisation with bovine and avian PPDs did not cause a significant reduction in the number of SIT and CIT test reactors compared with the control group. In fact, a higher number of reactors was observed after the prior tuberculin injection in the pre-sensitised group (p > 0.05). No significant effect was observed on IGRA and P22 ELISA due to corticosteroids administration. Nevertheless, a previous PPD injection affected the IGRA performance in some groups.ConclusionsThe application of topical corticosteroid 24 h before reading the SIT and CIT tests can reduce the increase in skin fold thickness and subsequently significantly decrease the number of positive reactors. Corticosteroids used can be detected in hair samples. A previous pre-sensitisation with bovine and avian PPDs does not lead to a significant reduction in the number of intradermal tests reactors. These results are valuable in order to improve diagnosis of caprine TB and detect fraudulent activities in the context of eradication programs.

Epithelial hypertrophy - an unusual representation of herpes simplex keratitis

Herpes simplex virus (HSV) keratitis is believed to be an important cause of infectious blindness, mainly resulting from stromal opacification. It has multiple manifestations with involvement of the individual layers of the cornea (epithelium, stroma, and endothelium). We report a rare presentation of HSV keratitis, a clinical representation that includes epithelial hypertrophy and subepithelial activity with the appearance of multiple fronds of vessels arising from superficial vascularization with infiltration, which reduced on administration of topical corticosteroids and systemic antivirals. Epithelial hypertrophy also regressed over time.

Erythrodermic tinea corporis with iatrogenic Cushing’s syndrome.

Dermatophytosis is a rampantly emerging challenge in the developing countries. However, erythroderma secondary to tinea corporis is rare. It is strange how alongside the prevailing corticophobia there are, albeit exceptionally, cases of excessive administration of topical corticosteroids, as happened in the ’70s in the developed countries. Inadvertent abuse of topical corticosteroids (2, 3) leads to not only a change in the morphology of the lesions but also to uncontrolled replication of the fungi making the disease widespread, chronic, and recurrent in nature. Moreover, the inappropriate use of corticosteroid preparations can cause both local and systemic (1, 4, 5) adverse effects related to any one of the variables as follows: quantity per application, frequency of application, duration of treatment, potency, vehicle used and site of application. Children are especially more prone to the systemic adverse effects of these drugs because their skin has poorly developed barrier function and mainly because of a higher skin surface area/weight ratio compared to adults.

Recent Approaches on Novel Topical Delivery Systems for Atopic Dermatitis Treatment.

Atopic dermatitis is a chronic inflammatory disease of the skin, which is characterized by itching, erythema, and eczematous lacerations. It affects about 10 % of adults and approximately 15-20 % of children worldwide. As a result of genetic, immunologic, and environmental factors, the disease manifests itself with the impaired stratum corneum barrier and then immunological responses. Topical administration of corticosteroids and calcineurin inhibitors are currently used as the first strategy in the management of the disease. However, they have low skin bioavailability and some side effects. The nanocarriers as novel drug delivery systems could overcome limitations of conventional dosage forms, owing to increment of poorly soluble drug' solubility, then its thermodynamic activity and, consequently, its skin permeation. Also, side effects of the drug substances on the skin could be reduced by the nano-sized drug delivery systems due to encapsulation of the drug in the nanocarriers and targeted drug delivery of drug substances to the inflammated skin areas. Thereby, there have been available numerous research studies and patents regarding the use of nanocarriers in the management of atopic dermatitis. This review focuses on the mechanism of disease and development of nanocarrier based on novel drug release systems in the management of atopic dermatitis.

Punctum and Canalicular Anatomy for hydrogel-based Intracanalicular Insert Technology

Aim: Despite advances in cataract surgery, postoperative ocular inflammation and pain occurs. To address compliance issues with topical corticosteroid administration, a hydrogel-based dexamethasone insert was developed for intracanalicular administration. The objective is to understand the anatomy to best administer the insert and learn how the anatomy and hydrogel properties help retain the insert in the canaliculus over time. Materials & methods: Human cadavers (n =5) were dissected to assess dimensions of punctum and canaliculus as part of drug discovery and development. Results & conclusions: Mean measures for punctal diameter was 0.5±0mm and vertical canaliculi length was 2.4±0.5mm and width was 1.6±0.5mm. Vertical canalicular width was larger than the punctal opening, a critical understanding for placing and retaining intracanalicular inserts.

Triamcinolone acetonide loaded-cationic nano-lipoidal formulation for uveitis: Evidences of improved biopharmaceutical performance and anti-inflammatory activity

Topical administration of corticosteroids is the cornerstone treatment of anterior uveitis, but poor corneal penetration and retention cause hindrance in their therapeutic utility. The conventional eye drops are less valuable in conditions where inflammation reaches deeper regions of the eye. Therefore, there is a clear need for an effective drug delivery system, which can increase corticosteroid penetration after topical application. To address this, cationic nanostructured lipid carriers of the drug triamcinolone acetonide (cTA-NLC) were prepared. The cTA-NLC were prepared by a hot microemulsion method and evaluated for drug release, permeation, cell uptake, cytotoxicity, anti-inflammatory activity and ocular irritancy. The cTA-NLC are nanometric in size (< 200 nm), with a zeta potential of about +35 mv and % drug EE of 88 %. The nanocarriers exhibited slow and sustained release of around 84 % in 24 h and transcorneal drug permeation of 51 % in 8 h. The nanocarriers exhibited no cytotoxicity (% cell viability of>90 %). The cell uptake study showed that nanocarriers could retain inside the cells for 24 h. The developed formulation could significantly reduce the TNF-α level in LPS induced inflamed cells. The studies indicated that cTA-NLC could be a promising option for the topical treatment of uveitis.

Clinical Pharmacology of Corticosteroids.

Corticosteroids have numerous applications in treating inflammation and diseases of immune function based on their significant anti-inflammatory and immunosuppressive effects. Corticosteroids modulate immune function through various effects in the nucleus of numerous cells. When used in pharmacologic doses to suppress allergic responses or inflammation, these agents can cause numerous adverse effects associated with an excess of glucocorticoid activity. Prolonged use (>2 wk) results in suppression of the hypothalamic-pituitary-adrenal axis, which requires tapering of doses. Dosing strategies for systemic corticosteroids are designed to minimize the risk for hypothalamic-pituitary-adrenal axis suppression. Topical administration of corticosteroids, including oral inhalation, is often used to avoid the significant adverse effects associated with chronic use. Inhaled corticosteroids are potent synthetic agents that exert their actions locally in the airways but can cause systemic effects based on several factors that influence systemic bioavailability. Inhaled corticosteroids are the cornerstone of asthma therapy and important options for COPD in patients who experience frequent exacerbations. By the nasal route, they are the most effective therapy for treating moderate-to-severe allergic rhinitis.

Application of Laser Flare Photometry in the Quantification of Blood–Aqueous Barrier Breakdown after Micro-incision Vitrectomy

ABSTRACTPurpose: The purpose of the study is to quantify aqueous flare using laser flare photometry (LFM) in patients undergoing 25-G pars plana vitrectomy (PPV) and assess the need for postoperative topical corticosteroid administration .Methods: Prospective evaluation of 50 eyes (50 patients) was performed using LFM until day 30 postoperative. Duration of surgery, indication of PPV, and use of laser and/or cryotherapy were noted. Topical corticosteroids were used if mean LFM values were >50, or if there was anterior chamber fibrin.Results: Mean age of the subjects was 48.62 ± 10.07 years. The preoperative LFM value for 50 subjects was 17.42 ± 25.20. Topical corticosteroids were initiated in only 22 patients. The LFM values of subjects were not different from baseline at 1 month whether or not the subjects received corticosteroids (p > 0.106).Conclusions: With 25-G PPV, there is minimal breakdown of blood–aqueous barrier. LFM helps in monitoring postoperative inflammation, obviating the need for topical corticosteroids in significant number of patients.

Drug-induced oral mucous membrane pemphigoid: a case report

Observation: An 82-year-old patient treated with the antihistamine ebastine (Kestin ® ) for allergic rhinitis presented for gingival pain. The diagnosis of mucous membrane pemphigoid was suspected after a positive pinch test. Blood examinations highlighted AC anti-PBGA2, and the gingival biopsy showed an epithelioconjunctival delamination and the presence of anti-IgA antibody and C3 deposition along the basal of the membrane. Topical corticosteroid administration was initiated. The symptoms improved but elevated IgA and C3 levels persisted. He underwent a complete remission on cessation of ebastine treatment. Commentary: Mucous membrane pemphigoid is an autoimmune disease whose origin remains unclear. The aim of the treatment is to decrease the symptoms, but full recovery of the patients is exceptional. We report here a clinical case with symptom resolution because of the ebastine withdrawal. Ebastine can thus be suspected as a cause if a patient presents with oral symptoms of mucous membrane pemphigoid.

Novel inulin-based mucoadhesive micelles loaded with corticosteroids as potential transcorneal permeation enhancers

In this work a new copolymer of inulin (INU) derivatized with ethylendiamine (EDA) and retinoic acid (RA), named INU-EDA-RA, was synthetized, characterized and employed to produce micelles as carriers for topical administration of corticosteroids for the potential treatment of diseases of posterior eye segment. Spectroscopic analysis confirmed a molar derivatization degree of 11.30 and 4.30% in EDA and RA, respectively. INU-EDA-RA micelles are capable of strong mucoadhesive interactions which result time-independent and stable over time but concentration depending. Moreover micelles are able to encapsulate efficiently from 3 to 13% (w/w) of lipophilic drugs, as dexamethasone, triamcinolone and triamcinolone acetonide. Drug loaded micelles are stable for three months when stored as freeze-dried powders and able to release high amount of drug when compared to drug dissolution profiles from suspensions. Moreover, drug loaded micelles are compatible with different ocular cell lines that are also able to internalize fluorescent micelles. Finally, drug loaded micelles enhance drug fluxes and permeability coefficients across corneal epithelial cells, thus reducing drug loss due to retention inside the cells.

Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus.

Background:Lichen sclerosus (LS) is an inflammatory dermatosis with autoimmune pathogenesis. Although relatively common, its true incidence is unknown and likely underestimated. LS is usually anogenital, but in around 10% of patients, it can present as extragenital lesions. Continuous administration of topical corticosteroids is the mainstay of medical treatment. Other treatments are available but are only occasionally prescribed along with or instead of topical steroids. Injection of platelet-rich plasma (PRP) into affected areas has been reported to result in the regeneration of normal skin. In this study, we aimed to evaluate the safety, symptom resolution, and objective improvement in patients with autoimmune condition like genital LS after treatment with PRP.Methods:Over a 2-year period at FBW Gynaecology Plus, we had a total of 28 patients with confirmed LS on biopsy, unresponsive to topical steroid treatment. After acquiring informed consent, patients’ own blood was centrifuged on site and injected under local anesthesia to the external genitalia.Results:Almost all of our patients showed clinical improvement in the size of their lesions, and in 8 cases, lesions totally disappeared after treatment with PRP. Symptoms disappeared in 15 of the 28 patients after treatment, with no need for further steroid therapy in 23 patients. Thirteen women experienced partial symptom relief.Conclusions:Based on our limited findings, we hypothesize that PRP presents a potential alternative to topical steroids for treatment of vulvovaginal autoimmune conditions such as LS. A larger pilot and/or randomized controlled trial study is required to evaluate this finding further.

The effects of oral and topical corticosteroid in rabbit corneas.

BackgroundTo determine the most effective route of administration of corticosteroids in the treatment of ocular surface disease, by characterizing the difference between oral prednisolone and topical dexamethasone administration using an animal model.MethodsPharmacokinetic analyses determined the corticosteroid concentrations in the normal ocular tissues of rabbits after oral or topical administration of corticosteroids using LC-MS/MS. In wound healing analyses, the area of the epithelial defect created by keratectomy using a 6-mm trephine was calculated with an image analyzer using an orally or topically steroid-administrated animal model. The average size of basal epithelial cells, the frequency of mitotic basal epithelial cells, the number of squamous cells, and the number of hypertrophic stromal fibroblasts were determined in the enucleated corneal tissues after wound closure.ResultsBy slit lamp examination, no remarkable differences were observed between orally and topically administered groups. Pharmacokinetic analyses showed that the distribution of dexamethasone after topical administration was superior to that after oral administration in the cornea. In contrast, both concentrations of corticosteroid applied topically and orally were similar with regards to AUCs (area under the concentration-time curve) in the conjunctiva. Although the healing rate was slower in the topical group, all corneas were almost healed within 96 h in the wound healing analysis. According to the histological analyses of epithelial cells, the average basal cell size was larger, the frequency of mitotic basal cells was greater, and the number of squamous epithelial cell layers was lower in the topically administered group although all of these differences were with no statistical significance. However, the number of hypertrophic stromal fibroblasts in the topically administered group was significantly lower than that in the orally administered group.ConclusionsThere are different distributions and effects between orally and topically administered corticosteroids on the ocular surface. The data may provide the useful information in selecting the appropriate route of corticosteroid application for the treatment of ocular surface disease.

Potential preventive effects of proactive therapy on sensitization in moderate to severe childhood atopic dermatitis: A randomized, investigator-blinded, controlled study.

Proactive therapy for atopic dermatitis (AD) effectively prevents exacerbation. However, its role in preventing subsequent sensitization to allergens has not been prospectively studied. We investigated whether proactive therapy for AD can effectively impact immunological parameters in a randomized, investigator-blinded, parallel group study. Thirty patients aged 3 months to 7 years with moderate to severe AD who had undergone an AD educational program were allocated to a proactive treatment group or a reactive treatment group. During the disease control period, patients in the proactive group performed intermittent preventive application of topical corticosteroid for 1 year. Changes in the severity scoring, quality of life measures and immunological parameters (serum thymus and activation regulated chemokine [TARC], total immunoglobulin E [IgE] and house dust mite-specific IgE levels) were evaluated and compared between the proactive and reactive treatment groups. Although the average topical corticosteroid ointment use per day in both groups was not significantly different, the severity and quality of life scores were significantly lower in the proactive group than in the reactive group at the final visit. In addition, compared with baseline levels, serum TARC levels remained significantly lower during proactive therapy, while house dust mite-specific IgE levels were significantly increased only in the reactive group. The results suggest that in addition to controlling the severity of AD, intermittent preventive administration of topical corticosteroids may prevent an increase in aeroallergen-specific IgE levels in patients with childhood AD. The use of TARC levels as a biomarker for AD remission is also supported.

Effects of topical corticosteroid administration on intraocular pressure in normal and glaucomatous cats.

The objective of this study was to determine the effect of topical corticosteroid (CCS) therapy on intraocular pressure (IOP) in normal cats and cats with primary feline congenital glaucoma (FCG). Five normal and 11 FCG cats were studied in two cohorts. IOP was measured by a single, masked observer, once daily, 3-5 days/week throughout the course of CCS treatment and for up to 11 days after treatment discontinuation. One eye per cat was randomly assigned for treatment twice daily with CCS; balanced salt solution (BSS) applied to the contralateral eye served as a control. Differences between eyes and between weeks of the study period were calculated for each cat. A positive response to CCS was defined as a consistent >15% or >25% higher IOP in the treated relative to control eye in normal and FCG cats, respectively. A total of 8 of 11 FCG cats responded to topical CCS after 1-5 weeks of treatment with an increase in IOP relative to the untreated eye (maximum IOP discrepancy of 56 mmHg). Two of five normal cats responded to topical CCS with an appreciable, but clinically unimportant increase in IOP in the treated eye (maximum IOP discrepancy of 6.4 mmHg). Our data indicate that the incidence of steroid-induced IOP elevation in cats is lower than that of previously published feline studies. Cats with preexisting compromise in aqueous humor outflow may show a greater, clinically relevant response to topical CCS than normal cats.

Пимекролимус в лечении атопического дерматита у детей. Вопросы безопасности и эффективности. Опыт пятилетнего применения

A growth in the incidence rate for atopic dermatitis (AD) in infants has been observed for this decade. Early formation of AD (at the age of 3-6 months) is observed in 45% of infants, and in 60% of infants - during the first year of life. As many as 65% of children (by the age of 7) and 74% of children (by the age of 16) suffering from AD have a spontaneous remission of the disease. As many as 20-43% of children suffering from AD further develop bronchial asthma, and the incidence rate of allergic rhinitis is twice as high. In spite of the fact that topical corticosteroids (TCS) are prescribed frequently enough, there is a need in the non-hormonal therapy due to poor compliance with the TCS treatment regimen in connection with side effects. Treatment of AD is often complicated by the colonization with Staphylococcus aureus and inefficacy of the external therapy with topical corticosteroids because many patients with AD have a high level of IgE against the superantigen of Staphylococcus. 1% pimecrolimus cream (PIM) and TCS were compared in a long-term large-scale study involving younger children suffering from mild to moderate AD. Materials and methods. The five-year open-label study involved 2,418 children, who were randomized into groups receiving PIM (n = 1205; in case of an aggravation - short-term administration of TCS) or TCS (n = 1213). The main goal of the study was to compare the safety of these two methods of treatment; an auxiliary goal was to confirm the long-term efficacy of PIM. Treatment was considered to be successful if the score based on the IGA scale was 0 (clean skin) or 1 (almost clean). Results. The effect in both groups of the drugs - PIM and TCS - was fast, and the success of treatment was recorded for &gt;50% of patients by Week 3. In both groups, treatment was determined to be successful after 5 years in &gt;85% of patients, and treatment of manifestations of AD on the face was efficient in 95% of all subjects. In the PIM group, the need in steroids was considerably lower than in the TCS group (7 days of administration vs. 178 days in the TCS group). In both groups, there were adverse events similar by their nature and frequency, and no disorders of humoral or cellular immunity were revealed. Conclusions. The long-term administration of PIM in case of mild to moderate AD in children was revealed to be safe and had no effect on the immune system. When PIM was used, the need in corticosteroids was considerably reduced (steroid-preserving effect). These data confirm that PIM is as efficient as TCS and can be used as the first-line therapy for mild to moderate AD in infants and younger children.