SAFETY AND EFFICACY OF BOTULINUM TOXIN TYPE A IN THE MANAGEMENT OF MODERATE TO SEVERE FACIAL WRINKLES

Abstract

Background & Aim: Botulinum Toxin A is the most potent serotype, involved in the management of facial rejuvenation. The safety and effectiveness of Botulinum Toxin Type-A was evaluated for managing moderate to severe facial wrinkles in real-world clinical practice. Materials and Methods: Male and female subjects with moderate to severe facial wrinkles were included. Treatment was administered to single or multiple facial zones, depending on the case. The primary objective was to assess the safety and tolerability of the formulation used. The secondary objectives were to assess the effectiveness of the treatment based on the Investigator and subject-assessed Modied Global Aesthetic Improvement Scale (GAIS). The study involved 100 participants, mostly females (64%), with a mean (±S.D.) age of Results: 40.7±6.2 years. Eight of them reported a total of 10 adverse events (AEs), such as headache (3%) and heaviness of forehead (2%), but none reported serious adverse events (SAEs). The study revealed statistically signicant improvements, as assessed by the investigator and the subjects, in zones 1, 2, and 3 of the GAIS (Global Aesthetic Improvement Scale). Moreover, the percentage of subjects reporting "I look younger" increased from 3% in visit 1 to 70.7% in visit 4, signicantly. Botulinum toxin A appears to be well-tolerated and effective treatment opti Conclusion: on that enhances facial appearance and quality of life. It was associated with very few to no treatment-associated adverse events (TEAEs) and serious adverse events (SAEs).