Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
Condition: Sun-induced Wrinkles
Intervention: Dysport; Xeomin
Intervention description: Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.; Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: botulinum toxin,; wrinkles

Summary:

      this study was proposed to provide more scientific and objective data on the clinical and
      aesthetic effects of these two toxins (Dysport and Xeomin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject agreement to provide written informed consent and the willingness and ability
             to comply with all aspects of the protocol;

          -  Female subjects;

          -  Phototype I to IV;

          -  Subjects aged between 18 and 60 years;

          -  Subjects naive for BT-A treatment;

          -  Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left
             and right side of forehead under maximum voluntary contraction of the frontalis m.
             according WSS;

          -  Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual
             Scale;

          -  Medical history and physical examination which, based on the investigator's opinion,
             do not prevent the subject from taking part in the study or from making use of the
             products under investigation;

          -  Subjects of childbearing age should present a negative urine pregnancy test at
             baseline and should be using a highly effective contraceptive method during all study;

          -  Availability of the subject throughout the study (5 months);

          -  Subject agreeing not to undergo other cosmetic or dermatological procedures during the
             participation in the study;

          -  Subjects with sufficient schooling and knowledge to enable them to cooperate to the
             degree required by the protocol.

        Exclusion Criteria:

          -  Pregnant women or women intending to become pregnant in the following 5 months after
             screening;

          -  Lactation period;

          -  Subjects participating in other clinical trials;

          -  Any prior surgery affecting the frontalis and/or orbicularis muscles, prior
             blepharoplasty or brow lift;

          -  Any prior cosmetic procedures, including fillers, or scars that may interfere with the
             study results;

          -  Subjects with neoplastic, muscular or neurological diseases;

          -  Subjects taking aminoglycoside and penicillamine antibiotics, quinine or Ca2+ channel
             blockers;

          -  Subjects with inflammation or active infection in the area to be injected;

          -  Subjects presenting evident facial asymmetry;

          -  Subjects with a history of adverse effects, such as sensitivity to the components of
             any of the study drug formula, ptosis or any other adverse effect which, in the
             investigator's opinion, should prevent the subject from participating in the study;

          -  Subjects presenting Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron
             disease;

          -  Subjects with coagulation disorders or taking anticoagulants;

          -  Subjects with known systemic autoimmune diseases;

          -  Subjects with a history of non-adherence to medical treatment or showing unwillingness
             to adhere to the study protocol;

          -  Any condition that, in the opinion of the investigator, can compromise the evaluation
             of the study.