(Acting as CRO) – Study Title: Phase IV, randomized, controlled, blinded study of action halos and muscle activity of two commercial preparations of botulinum toxin type A (Dysport® and Botox®) administered in the upper third of the face”].
Study End Date: May/2008
PHASE IV Clinical Trials
These studies assess whether the results obtained in the previous phase are applicable to a large portion of the patient population. At this stage, the drug has already been approved for marketing. The advantage of Phase IV studies is that they allow long‑term monitoring of the drug’s effects, including the identification of new adverse reactions.
After all stages have been completed, the regulatory authorities — in Brazil’s case, ANVISA — evaluate the results and, if satisfactory, grant the drug’s registration. Once registered, the medication is authorized to be prescribed by physicians, dentists, and other duly qualified professionals.