Study Comparing Treatment With Alluzience vs Reconstituted Toxin
Condition: Glabellar Frown Lines
Intervention: Alluzience; powder BoNT-A (BOTOX/Vistabel)
Intervention description: Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection; Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to
      investigate subject treatment perception and Investigator treatment experience when using
      Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of
      glabellar lines (GL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female 18 to < 65 years of age.

          2. Moderate to severe GL at maximum frown as assessed by the Investigator.

          3. Female of non-childbearing potential (i.e., postmenopausal [absence of menstrual
             bleeding for 1 year prior to screening, without any other medical reason], or has
             undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential
             with a negative urine pregnancy test at screening and baseline, and agrees to use a
             highly effective and approved contraceptive method for the duration of the study.

          4. Time and ability to complete the study and comply with instructions.

          5. Understands the study requirements and signed the informed consent form (ICF).

          6. Subjects who have planned to undergo aesthetic facial treatment with powder toxin at
             the study site.

          7. Previous use of any approved botulinum toxin in facial areas.

        Exclusion Criteria:

          1. Previous use of any botulinum toxin in facial area within 6 months prior to study
             treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the study product or any
             botulinum toxin serotype.

          4. Any known contraindication such as subject with bleeding disorder or subject currently
             using anticoagulants.

          5. Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated
             area within 3 months before baseline.

          6. Previous soft tissue augmentation with any permanent (non-biodegradable such as
             silicone, polyacrylamide, etc) or semi-permanent (i.e., calcium hydroxylapatite,
             poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous
             fat in the treatment area.

          7. Subject has any prior or current psychiatric illness (e.g. Psychosis, depression,
             anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or
             antipsychotic medication that, in the Investigator's opinion, could affect the
             subject's safety and/or participation in the study.

          8. Other concurrent medical conditions, therapy, or other condition that, in the
             Investigator's opinion, would interfere with the evaluation of the study medication,
             safety or efficacy, and/or put the subject at risk if he/she participates in the
             study.

          9. Participation in an investigational device or drug study within 30 days prior to study
             treatment or plans to enroll in any other investigational study during participation
             in this study.

         10. Study site personnel, close relatives of the study site personnel (e.g. parents,
             children, siblings, or spouse), employees or close relatives of employees at the
             Sponsor company.