A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines

Study Overview
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Brief Summary
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A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.

Detailed Description
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Clarification regarding injection volumes for the different study groups: Subjects will be randomized to Group A or Group B (1:1). Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.) Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.). The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.

Official Title
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A Randomized, Evaluator-blinded, Comparative Study to Evaluate the Efficacy and Safety of Different Injection Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: Azzalure


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Women, 18 to 64 years of age Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator. Key Exclusion Criteria: Subjects previously treated with any botulinum toxin product. Pregnant or breast feeding women or women intending to get pregnant in the next 12 months. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator. 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. Subjects with previous or current diagnosis of Bell's paresis. Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants. Subjects who are taking anticholinergics or aminoglycoside antibiotics. Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results. Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azzalure 10 Speywood units/injection<br>Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U) | Drug: Azzalure<br> <br> * Other names: botulinum toxin type A;|
| Active Comparator: Azzalure, 10 Speywood units/injection<br>Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U) | Drug: Azzalure<br> <br> * Other names: botulinum toxin type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale. (However no primary outcome measure is defined in the study protocol) | To evaluate effect on glabellar line severity | Month 1 |