Glabellar Frown Lines
Conditions
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.
Interventions
DRUGAzzalure
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale | Day 0, 1, 3, 7, 14, month 3, 4 and 6 | To evaluate effect on glabellar line severity |
| Adverse Event reporting | Day 0-180 | To evaluate long term safety throughout the study period |
| Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement | Day 0, 1, 3, 7, month 1, 3 and 6 | To evaluate the Compound Muscle Action Potential using electroneurography |
Countries
Sweden
Outcome results
None listed