A randomized, evaluator-blinded, comparative study toevaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure®, in the glabellar lines.

Q-MED AB0 sitesStarted: December 19, 2013Last updated: March 16, 2015

Conditions

Drugs

Trial Snapshot

No summary available.

•1. Women, 18 to 64 years of age (at screening visit).
•2. Subjects seeking treatment for moderate to severe glabellar lines (grade 2-3 at rest using ‘Merz Aestethic Scale for Glabellar lines at rest’) when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Subjects previously treated with any botulinum toxin product.
•2. Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
•3. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
•4. Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.
•5. Subjects with previous or current diagnosis of Bell’s paresis.
•6. Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
•7. Subjects who are taking anticholinergics or aminoglycoside antibiotics.
•8. Subjects with active inflammation or infection in the areas to be treated.
•9. Subjects with known hypersensitivity to any compound of the study products used in the study.
•10. Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
•11. Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.

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