Three double-blind, randomized, placebo-controlled, clinical studies evaluated the efficacy of Dysport® for use in the temporary improvement of the appearance of moderate to severe glabellar lines. These 3 studies enrolled healthy adults (ages 19—75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had marked ptosis, deep dermal scarring, or a substantial inability to lessen glabellar lines, even by physically spreading them apart. The subjects in these studies received either Dysport or placebo. The total dose was 50 units delivered in equally divided aliquots to specified injection sites.
Additional endpoints for each of the studies were post-treatment glabellar line severity of none or mild with at least a 1-grade improvement from baseline for separate investigator and subject assessments at Day 30.
Studies GL-1 and GL-3 were 6- and 5-month (respectively) single-dose studies comparing Dysport to placebo. GL-2 was a study of Dysport vs placebo in subjects who had received up to 4 treatments of Dysport over the course of the study.
Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. This product may contain trace amounts of cow’s milk protein. Patients known to be allergic to cow’s milk protein should not be treated with Dysport. Dysport is contraindicated for use in patients with infection at the proposed injection site(s).
Ingredients in Dysport
Active ingredient: (botulinum toxin Type A)
Inactive ingredients: human albumin, and lactose. Dysport may contain cow’s milk protein.
DOSAGE AND ADMINISTRATION
The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
WARNINGS AND PRECAUTIONS
Facial Anatomy in the Treatment of Glabellar Lines
Caution should be exercised when administering Dysport to patients with surgical alterations to the facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart.
Do not exceed the recommended dosage and frequency of administration of Dysport. In clinical trials, subjects who received a higher dose of Dysport had an increased incidence of eyelid ptosis.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin.
Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of Dysport.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases.
A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Intradermal Immune Reaction
The possibility of an immune reaction when injected intradermally is unknown.
Learn more about Drug Interactions.