In accordance with international standards, clinical trials are required to compare the clinical efficacy and safety of generic drugs with the original drug’s profile. Aim. To compare the effectiveness and safety of domestic versus foreign topical drug therapies of combined glucocorticosteroids containing betamethasone, clotrimazole, and gentamicin, for patients with eczema. Material and methods. A prospective open randomized controlled trial was conducted with 2 parallel groups in outpatient care. The procedures used to assess the safety and effectiveness of the preparations being studied were identical in both groups. In order to quantify the evaluation of the clinical trial data, current dermatological severity scales for eczema were used: an investigator global assessment scale, an index of prevalence and severity of the eczema, and a patient global assessment scale for the severity of the eczema. Statistical analysis was performed with the help of special software: statistical package R, version 3.2.1. The results. A conclusion that the domestic combined topical preparation in the form of a cream is «not less effective» can be made in the event that the upper limit of the one-sided 95% confidence interval of the difference of the IGA scale value does not exceed a value of 0.395 points. For patients in the protocol population (PP population) this value was 0.00004801, which is less than the protocol value of 0.395. For the population of all patients included in the study (ITT population), the value was 0.00001306, which is less than the protocol value of 0.395 points. The conclusion about the similarity of safety profiles is based on a comparative frequency analysis of adverse events, performed by means of the chi-squared test, for patients of the safety population with adverse events on at least one visit, for both groups. Conclusion. In an open randomized comparative study conducted in accordance with GMP criteria, a sufficient sample of two representative groups of patients shows similar clinical efficacy and safety profiles.