Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
Condition: Sun-induced Wrinkles
Intervention: Botulinum toxin
Intervention description: Drug: Botulinum toxin
Indications for eligibility and total doses that will be applied in each part of the face, at visit 1:
Upper face:
Crow's feet wrinkles - 70 units
Glabella - 50 units
Forehead - 40 units
Mid face:
Lower eyelid - 5 units
Nasal wrinkles - 20 units
Malar wrinkles - 10 units
Lower face:
Peri-oral wrinkles - 15 units
Asymmetric smile or gummy smile - 5 units
"Cellulitic chin" - 20 units
Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.
Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs.
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Botulinum Toxin; Rejuvenation; Facial dynamic wrinkles

Summary:

      This is an open-label and phase IV study of full face injections of variable doses of
      botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator
      and subjects will know the injection local and doses of the study drug. Patients will be
      randomized into 3 different groups. Each group will receive a specific dose according with
      the indication evaluated by the investigator. Six visits will be schedule in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent;

          2. Subjects aged between 30 and 60 years;

          3. Skin Fitzpatrick Phototypes I to VI;

          4. Subjects that never received BT-A or who had previous injections of BT-A in no more
             than one third of the face with in the last 6 months;

          5. Subjects presenting at least two indications for treatment with BT-A in each third of
             the face;

          6. Medical history and physical examination which, based on the investigator's opinion,
             do not prevent the patient from taking part in the study and use the product under
             investigation;

          7. Subjects of childbearing age should present a negative urine pregnancy test (instant
             test) at baseline and should be using an effective contraceptive method (oral or
             injectable contraceptive, for at last three months, and use of preservative; subjects
             with: hysterectomy, oophorectomy or tubal ligation);

          8. Availability of the patient throughout the duration of the study (24 weeks);

          9. Subjects that agree not to undergo other cosmetic or dermatological procedures during
             the study;

         10. Subjects with sufficient schooling and awareness to enable them to cooperate to the
             degree required by the study protocol.

        Exclusion Criteria:

          1. Pregnant women or women intending to become pregnant during the study;

          2. Subjects participating in other clinical trials;

          3. Presence of scars on the face that may interfere with the result of study;

          4. Subjects with neoplastic, muscular or neurological diseases;

          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. Subjects with inflammation or active infection in the face;

          7. Subjects with a history of sensitivity to the components of the formula;

          8. Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive
             dermatochalasis, deep dermal scarring or thick sebaceous skin.

          9. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron
             diseases;

         10. Subjects with coagulation disorders or using anticoagulants;

         11. Subjects with known systemic autoimmune diseases;

         12. Subjects clinically diagnosed anxiety disorder or any significant psychiatric disorder
             (e.g. depression) that, in the opinion of the Evaluator, might interfere with the
             Subject's participation in the study;

         13. Subjects with a history of medical treatment non-adherence or showing unwillingness to
             adhere to the study protocol.