Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006
Condition: Glabellar Frown Lines
Intervention: DWP-450 (Botulinum purified neurotoxin, Type A)
Intervention description: Botulinum toxin, Type A
Intervention MeSH terms: Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This is an open label safety study
Enrollment: 570.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glabellar Lines; Botulinum toxin, Type A

Summary:

      The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified
      Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated
      with corrugator and procerus muscle activity in adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be an adult 18 years of age and over

          -  Subject is able to provide informed consent and comply with study instructions

          -  Subject has moderate-to-severe glabellar lines on maximum frown as assessed by the
             investigator and 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)

          -  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, nursing 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