A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
Condition: Glabellar Frown Lines
Intervention: Botulinum toxin, Type A; 0.9% sterile, unpreserved saline
Intervention description: 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum
      purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines
      associated with corrugator and/or procerus muscle activity in adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects is an adult, of at least 18 years of age

          -  Subject is able to provide informed consent and comply with study instructions

          -  Subject has moderate to severe glabellar lines at maximum frown as assessed by the
             investigator using the GLS

          -  Subject has moderate to severe glabellar lines at maximum frown as assessed by the
             subject using the GLS

          -  Subject is willing and able to complete the entire course of the study

        Exclusion Criteria:

          -  Previous treatment with botulinum toxin of any serotype in any area within the last 6
             months

          -  Previous treatment with any facial aesthetic procedure (e.g. injection with fillers,
             chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months

          -  Previous insertion of permanent material in the glabellar area

          -  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)

          -  Energy-based or cryo-therapy based treatment of facial muscles superior to the lateral
             canthus

          -  Any other planned facial aesthetic procedure during the trial period, superior to the
             level of the lateral canthus (subjects can continue with their usual skin care
             routine)

          -  Subjects who may not respond to 20 Units of botulinum toxin (e.g., inability to
             substantially lessen glabellar frown lines even by physically spreading them apart)

          -  Marked facial asymmetry

          -  Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis

          -  History of facial nerve palsy

          -  Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin

          -  Any active infection in the area of the injection sites

          -  Medical condition that may affect neuromuscular function (e.g., myasthenia gravis,
             Eaton-Lambert syndrome, amyotrophic lateral sclerosis)

          -  Evidence of recent alcohol or drug abuse

          -  Medical or psychiatric conditions that may increase the risk associated with study
             participation or may interfere with the interpretation of study results and, in the
             judgment of the Investigator, would make the subject inappropriate for entry into this
             study

          -  Pregnant or sexually active female subjects who are of childbearing potential and who
             are not willing to use an acceptable form of contraception

          -  Known allergy or hypersensitivity to botulinum toxin preparation

          -  Participation in another interventional clinical study within the last 30 days