A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
Condition: Canthal Lines
Intervention: Botulinum Toxin Type A; Placebo
Intervention description: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with 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: 335.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Canthal lines

Summary:

      This double-blind study has two parts for each subject (same population):

      Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

        -  To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of
           moderate to severe LCLs.

        -  To assess the subjects' level of satisfaction with the appearance of their LCLs compared
           to placebo.

      Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up
      to 1 year):

        -  To assess safety of Azzalure® following repeated administration in the improvement of
           moderate to severe LCLs.

        -  To assess the safety of Azzalure® when used concomitantly for improvement of moderate to
           severe LCLs and GLs.

        -  To assess the subjects' level of satisfaction with the appearance of their LCLs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 18 to 65 years of age (Screening visit),

          -  Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines "at maximum smile"
             determined by investigator at screening and baseline

          -  Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines "at rest" determined
             by investigator at screening and baseline

          -  The subject is a female of childbearing potential and has a negative urine pregnancy
             test (UPT) at screening and baseline

          -  Subjects who are not satisfied with their appearance at screening and baseline

          -  The subject is willing and able to comply with the requirements of the protocol and
             agree to adhere to the visit schedule, concomitant therapy prohibitions and must be
             compliant to the study instruction.

          -  The subject agrees to participate in the study, verified by dating and signing an
             approved written Informed Consent Form (ICF) and Photography Consent Form (PCF)
             (selected sites only if applicable) at the enrolment visit before any study procedures
             at screening

        Exclusion Criteria:

          -  Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow
             lift, or any prior cosmetic procedures or scars that may interfere with the evaluation
             of the investigator.

          -  Previous insertion of any permanent, semi-permanent or biodegradable material in the
             periorbital region or facial treatment with augmentation material (e.g. silicon
             injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12
             months prior to screening.

          -  Any prior treatment with botulinum toxin (of any serotype)

          -  Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser)
             or treatment with deep chemical peels and any other esthetic or dermatologic
             treatments or procedures in any area of the face within 12 months prior to screening.

          -  Any planned facial cosmetic surgery or procedures during the study period.

          -  Presence of any bleeding disorders

          -  Pregnant or lactating women or women who are planning pregnancy during the study.

          -  Known hypersensitivity to any of the test materials or related compounds.