Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles
Condition: Wrinkles
Intervention: Botulinum Toxin Type A - Azzalure; Botulinum Toxin Type A - Vistabel
Intervention description: One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.; One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Forehead Wrinkles Toxin

Summary:

      Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison
      study in subjects with moderate to severe forehead wrinkles.

      One botulinum toxin type A will be injected in one side of the forehead and the other one
      will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to
      each side of the forehead will be randomized.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female Subjects of any race, from 18 to 65 years old

          2. Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the
             Forehead Wrinkles Severity Scale) on both sides of the forehead

          3. Negative urine pregnancy test at the Baseline visit for Subjects of childbearing
             potential

        Exclusion Criteria:

          1. Subjects with a washout period for procedure(s)/treatment(s) on the forehead less
             than:

               -  Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2
                  weeks

               -  Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes)
                  1 month

               -  Ablative skin resurfacing

               -  Non-ablative dermal treatment for skin tightening (e.g. radio-frequency
                  treatments) 6 months

               -  Treatment with a BoNT-A 12 months

               -  Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic
                  acid preparations) 24 months

          2. Subjects who undergone a surgical facelift;

          3. Permanent or semi-permanent dermal fillers in the forehead area;

          4. Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A
             (1) and/or BoNT-A (2) (see package inserts);

          5. Concurrent use of treatments that affect neuromuscular transmission, such as
             curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases
             affecting the striated muscle and aminoglycoside antibiotics;

          6. Pregnant women, nursing mothers, or women who are planning pregnancy during the study;