Efficacy and Safety of Botulinum Toxin Type A Haemagglutinin Complex Next Generation (BTX-A-HAC NG) in Glabellar Lines
Condition: Glabellar Lines
Intervention: Botulinum toxin type A; Placebo
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to demonstrate the safety and the efficacy of a single
      injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex
      (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines
      between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after
      repeated injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures.

          -  Male or female subjects between 18 and 65 years of age.

          -  Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at
             Baseline (Day 1), as assessed by the ILA using a validated 4- point photographic
             scale.

          -  Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at
             Baseline (Day 1), as assessed by the SSA using a validated 4-point categorical scale.

          -  Are dissatisfied or very dissatisfied (Grade 2 or 3) with their glabellar lines at
             Baseline (Day 1), as assessed by the subject's level of satisfaction.

          -  Have a negative pregnancy test (for females of childbearing potential only). No
             childbearing potential is defined as post-menopausal for at least 1 year, surgical
             sterilisation at least 3 months before entering the study, or hysterectomy.

          -  Have both the time and the ability to complete the study and comply with study
             instructions.

        Exclusion Criteria:

          -  Previous treatment with any serotype of BTX.

          -  Any prior treatment with permanent fillers in the upper face including the glabellar
             lines area.

          -  Any prior treatment with any dermal fillers in the upper face including the glabellar
             lines area within the past 3 years and/or skin abrasions/resurfacing (whatever the
             interventional technic used) within the past 5 years, or photo rejuvenation or
             skin/vascular laser intervention within the past 12 months.

          -  Any planned facial cosmetic surgery during the study.

          -  A history of eyelid blepharoplasty or brow lifts within the past 5 years.

          -  An inability to substantially reduce glabellar lines by physically spreading them
             apart or lack of capacity to frown.

          -  An active infection or other skin problems in the upper face including the glabellar
             lines area (e.g. acute acne lesions or ulcers).

          -  Use of concomitant therapy, which in the investigator's opinion, would interfere with
             the evaluation of the safety or efficacy of the investigational medicinal product
             (IMP), including medications affecting bleeding disorders (antiplatelet agents and/or
             anticoagulants given for treatment or prevention of cardio/cerebro vascular diseases).

          -  Pregnant women, nursing mothers, or women who are planning a pregnancy during the
             study, or believe they may be pregnant at the start of the study. Throughout the
             course of the study, women of childbearing potential must use a reliable form of
             contraception (e.g. oral contraceptives for more than 12 consecutive weeks, or
             spermicide and condoms).

          -  Treatment with an experimental drug or use of any experimental device within 30 days
             prior to the start of the study and during the conduct of the study.

          -  Known allergy or hypersensitivity to any component of BTX-A-HAC NG.

          -  Clinically diagnosed significant anxiety disorder, or any other significant
             psychiatric disorder (e.g. depression) that might interfere with the subject's
             participation in the study.

          -  Use of medications that affect neuromuscular transmission, such as curare-like non
             depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside
             antibiotics, within the past 30 days.

          -  A history of facial nerve palsy.

          -  Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or
             thick sebaceous skin.

          -  The presence of any other condition (e.g. neuromuscular disorder or other disorder
             that could interfere with neuromuscular function), laboratory finding or circumstance
             that, in the judgement of the investigator, might increase the risk to the subject or
             decrease the chance of obtaining satisfactory data to achieve the objectives of the
             study.