Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum purified neurotoxin, Type A
Intervention description: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 352.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glabellar Lines; Botulinum purifies neurotoxin, Type A (DWP-450)

Summary:

      The purpose of this study is to demonstrate the safety of multiple doses of DWP-450
      (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe
      glabellar lines in adult subjects.
    

Eligibility criteria:

        Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to
        be eligible for enrollment in the study):

          -  Subjects must be an adult 18 years of age or 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 using the GLS

          -  Subject is willing and able to complete the entire course of the study

        Exclusion Criteria (A subject must not meet the following exclusion criteria in order to be
        eligible for enrollment in the stud)y:

          -  Previous treatment with botulinum toxin of any serotype in the forehead area within
             the last 8 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 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