Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines
Condition: Glabellar Lines; Wrinkles
Intervention: Dysport reconstituted at 1.5 mL (0.05 mL/injection); Dysport reconstituted at 2.5 mL (0.08 mL/injection)
Intervention description: Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.; Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety, efficacy, and subject and investigator
      satisfaction of 2 different injection volumes of Dysport in the glabellar lines.

        1. To determine the proportion of composite responders (based on blinded evaluator and
           subject assessments) who achieve at least a 1-point reduction from baseline in glabellar
           line severity score (GLSS) at maximum frown line on Day 30.

        2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.

        3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2
           visit (subject and blinded evaluator).

        4. To assess the subject's satisfaction with the treatment.

        5. To evaluate investigator satisfaction of treatment outcome.

        6. To evaluate subject psychological well-being.

        7. To evaluate subject age appraisal.

        8. To evaluate all adverse events during the course of the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Botulinum toxin naïve subject (facial area)

          2. Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe
             (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic
             Scale, as assessed by the treating investigator and the blinded evaluator.

        Key Exclusion Criteria:

          1. Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's
             milk protein

          2. Have rhytids of the glabellar region that cannot be smoothed out by manually spreading
             the skin apart

          3. Have a history or have signs and symptoms of eyelid or brow ptosis or signs of
             compensatory frontalis muscle activity, as judged by the investigator

          4. Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia
             gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of
             dysphagia or aspiration

          5. Are women who are pregnant or breast-feeding or who intend to get pregnant within the
             duration of the study

          6. Have an active inflammation or infection in the areas to be treated or had any prior
             surgery, tattoos, piercings, or scarring in the facial area that, in the opinion of
             the investigator, may interfere with the results

          7. Have had any previous insertion of any permanent or semi-permanent material,
             hyaluronic acid, or collagen fillers in the glabellar region

          8. Have any chronic or acute medical condition that, may pose a risk to the safety of the
             subject, or may interfere with the assessment of safety or efficacy in this study