IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Condition: Moderate to Severe Glabellar Frown Lines
Intervention: IncobotulinumtoxinA (Xeomin) (20 Units); Placebo
Intervention description: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.; The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over
      placebo by evaluation of treatment success analyzing the investigator's rating on the Facial
      Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients
      with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive
      one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day
      120.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or over

          -  Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on
             Facial Wrinkle Scale as assessed by investigator's rating: 0= 'none', 1= 'mild', 2=
             'moderate', 3= 'severe')

          -  Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on
             Facial Wrinkle Scale as assessed by patient's assessment: 0= 'none', 1= 'mild', 2=
             'moderate', 3= 'severe')

          -  Stable medical condition

        Exclusion Criteria:

          -  Previous treatment with Botulinum toxin of any serotype in the glabellar area within
             the last 8 month

          -  Previous treatment with any facial aesthetic procedure (e.g. injection with
             biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area
             within the last 12 month

          -  Previous insertion of permanent material in the glabellar area (regardless of the time
             between previous treatment and this study)

          -  Planned treatment with Botulinum toxin of any serotype in any other body region during
             the study period

          -  Any surgery in the glabellar area including surgical removal of the corrugator,
             procerus, or depressor supercilii muscles or a combination of these, or scars in the
             glabellar area and the surrounding areas (including eye brow)

          -  Any other planned facial aesthetic procedure during the trial period

          -  Inability to substantially lessen glabellar frown lines even by physically spreading
             them apart

          -  Marked facial asymmetry or ptosis of eyelid and/or eyebrow

          -  History of facial nerve palsy

          -  Any infection in the area of the injection sites