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

Phase 4

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: Azzalure

• Registration Number: NCT02108158
• Lead Sponsor: Galderma R&D

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-03-05
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azzalure, 10 Speywood units/injection	Azzalure	Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)
Azzalure 10 Speywood units/injection	Azzalure	Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)

Primary Outcome Measures

Name	Time	Method
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)	Month 1	To evaluate effect on glabellar line severity

Trial Locations

Locations (2)

Göteborgs Plastikkirurgiska Center; 🇸🇪 Gothenburg, Sweden

Anna Neuromuskulär Konsult; 🇸🇪 Uppsala, Sweden