Import substitution of botulinum toxin preparations in cosmetologist's practice: experience of using Miotox® preparation

Botulinum therapy is the most popular medical cosmetology procedure in the world. At the moment 9 preparations of botulinum toxin type A-hemagglutinin complex are officially registered in Russia, only Miotox® is available in liquid form as a solution for intramuscular injection. The study of pharmacoepidemiology of botulinum toxin preparations in cosmetology practice and studies to evaluate their efficacy and safety will allow to specify their clinical and pharmacological advantages. Objective. To study the pharmacoepidemiology, safety, tolerability and efficacy of Miotox® in cosmetology practice. Materials and methods. In 2021–2022, a pharmacoepidemiologic study based on questionnaire survey of 288 cosmetologists from 28 cities of Russia was conducted to study the use of botulinum toxin preparations in cosmetology practice. 42 female patients were included in the prospective clinical study on the efficacy and safety of Miotox® for the correction of wrinkles of the upper third of the face. The FACE-Q questionnaire was used to assess the quality of life, satisfaction, attitude of the patients to their appearance, to expression wrinkles in the interbrow and forehead area before and after the procedure. Objective assessment of wrinkle dynamics in the interbrow and forehead areas was performed using the ANTERA 3D® computerized technique (Miravex, Ireland). Results. The analysis of the pharmacoepidemiologic study showed an increase in the share of domestic preparations in the structure of prescriptions of botulinum toxin type A-hemagglutinin complex preparations for temporary correction of hyperkinetic facial wrinkles. The maximum effect of Miotox® administration in participants with interbrow wrinkles was observed after 14–21 days for all parameters (total size, depth and width); the total size of wrinkles in the interbrow decreased by 65%, on the forehead – by 79%, wrinkle depth – by 58% and 69%, respectively. Despite the decrease in the effect after 150 days after the drug application, the effect of the drug administration remained: the total size of wrinkles in the interbrow decreased by 25%, on the forehead – by 19%, wrinkle depth – by 25% and 26%, respectively, wrinkle width – by 3% and 1%, respectively. Conclusion. The findings confirm the good tolerability, efficacy, and a high safety profile of Miotox® in patients with hyperkinetic (facial) wrinkles.