Clinical trial NCT02108158: A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
measure: Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale
timeFrame: Day 0, 1, 3, 7, 14, month 3, 4 and 6
measure: Adverse Event reporting
timeFrame: Day 0-180
measure: Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement
timeFrame: Day 0, 1, 3, 7, month 1, 3 and 6
Locations:
city: Gothenburg
country: Sweden
facility: Göteborgs Plastikkirurgiska Center
city: Uppsala
country: Sweden
facility: Anna Neuromuskulär Konsult
Study officials:
affiliation: ANNA Neuromuskulär Konsult
name: Anna Rostedt Punga, MD
role: PRINCIPAL_INVESTIGATOR
References: