Galderma, a distributor of the botulinum toxin-based drug Azzalure, announced that from now on the drug will be officially approved as a treatment for lateral canthal folds (the so-called crow’s feet) in the European Union.
The French Agency for the Salubrious Safety of Medicines (Agence Nationale de Sécurité du Médicament et des Produits de Santé) has issued a positive opinion on the use of the drug to combat wrinkles in the corners of the eyes, Azzalure has already passed national registration in the UK, Ireland, Germany and Austria. Other EU member states are awaiting licenses in the impending weeks.
This enables Galderma to deliver healthcare practitioners with methodical support and complete medical education, as well as appropriate certifications, which will enable them to promote and demonstrate a high safety profile, excellent clinical effect and patient satisfaction with the combined treatment of glabella wrinkles and lateral canthal folds as well as azzalure price.
Azzalure is a botulinum toxin type A intended to temporarily improve the appearance of moderate to deep glabella wrinkles (vertical glabella crease), which usually becomes visible when a person frowns heavily, and / or lateral canthal lines (crow’s feet) visible in adults patients under 65 years of age at the moment of the widest smile in case the presence of these wrinkles exerts strong psychological and social pressure on the patient.
The drug was approved for use in aesthetic medicine in the European Union in 2009 under the brand name Azzalure, and under the same name or under its “second name” Dysport, it was licensed in more than 70 countries around the world and you buy facial fillers online .
The owner of the marketing authorization is Ipsen. Since 2007, the company has granted the Galderm brand the exclusive right:
- to develop;
- distribute Azzalure in the European Union, as well as in some countries of the Middle East and Eastern Europe.
The decision on a positive conclusion was made after a series of clinical studies in which 308 patients participated. These people, whose crow’s feet were in the moderate to deep stage, went through a double-blind study in which their lateral canthal folds were treated at the moment of their widest smile.
Of these, 252 were injected with 30 Spywood units (a unit of measure for botulinum toxin) on each side of the face in a three-phase, double-blind, placebo-controlled trial. 56 participants were treated in a two-phase, double-blind study to determine the optimal dose of the drug.
In a three-phase study, it was noted that Azzalure, compared with placebo, significantly reduced the severity of lateral canthal folds. Evaluation of subjects’ satisfaction with the result and appearance of the crow’s feet area after the procedure was defined as a statistically significant difference between the drug and placebo.
In total, 315 people participated in the open stage of the extended three-phase study. As part of the open stage, combined therapy was carried out to correct the glabella and lateral canthal folds at certain time intervals within a year after the first control visit (on average, about three procedures).
The nature and occurrence of adverse reactions observed with repeated simultaneous treatment of glabella and lateral canthal folds were comparable to that as if the participants in the experiment were undergoing botulinum toxin therapy for individual indications.
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