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

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

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Azzalure

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Göteborgs Plastikkirurgiska Center
  • Uppsala, Sweden
    • Anna Neuromuskulär Konsult

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Azzalure 10 Speywood units/injection; Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)	Drug: Azzalure; Other Names: botulinum toxin type A
ACTIVE_COMPARATOR: Azzalure, 10 Speywood units/injection; Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)	Drug: Azzalure; Other Names: botulinum toxin type A

What is the study measuring?

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

Other 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	To evaluate effect on glabellar line severity	Day 0, 1, 3, 7, 14, month 3, 4 and 6
Adverse Event reporting	To evaluate long term safety throughout the study period	Day 0-180
Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement	To evaluate the Compound Muscle Action Potential using electroneurography	Day 0, 1, 3, 7, month 1, 3 and 6

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Anna Rostedt Punga, MD, Anna Neuromuskulär Konsult

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (ESTIMATE): April 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 05PF1311; 2013-004646-42 (EUDRACT_NUMBER)