Clinical, pharmacological and legal validity of the use of combined topical agents for acne treatment in the practice of dermatologist

Practicing dermatovenereologist, as well as a doctor of any other specialization, should not only consider the clinical efficacy, safety and availability of selected drugs, but also know statutory instruments and current updates in legislation regulating medical practice when prescribing therapy. For this purpose, the article provides federal laws and sections that guide the doctor in order of medical care provision and patient informing, as well as the concepts of bioequivalence, therapeutic equivalence of drugs, efficacy, necessity of phase III and IV clinical trials performance, achievement of patient compliance in treatment are considered. Through the example of a combined agent, namely adapalene gel 0.1% + metronidazole 1%, the validity of its use in clinical practice of acne therapy not only on the basis of the degree of efficacy and safety of treatment, but also taking into account the legal aspects and precedents, is considered. In order to strengthen the clinical evidence base of the drug, a review of clinical observations and studies in the field of external therapy of acne of mild and moderate degree carried out in 2022—2025 in Russia is presented. Thus, a comprehensive approach to health care delivery that considers legal aspects at the level of federal legislation, medical regulatory documents in the field of clinical and drug supply and based on the understanding of the degree of efficacy and safety of selected drugs, guarantees the doctor both the patient treatment effectiveness and his own legal protection.