Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses
Condition: Skin Wrinkling
Intervention: AbobotulinumtoxinA (ABO); OnabotulinumtoxinA (ONA)
Intervention description: Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.; Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: wrinkles; botulinum toxin; abobotulinumtoxinA; onabotulinumtoxinA; field of anhydrotic effects

Summary:

      The purpose of this study is to assess the fields of anhydrotic effect (FAE) of
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),
      comparing both sweat gland and muscle activity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed consent

          2. Female subjects aged between 18 to 60 years

          3. Phototype I to IV

          4. Moderate to severe wrinkles in the forehead region on maximal contracture of the
             frontalis muscle according to the Wrinkle Severity Scale

          5. Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test
             sweat intensity scale, showing sweat on the forehead under standardized conditions

          6. Medical history and clinical examination that, in the investigator's opinion, do not
             prevent the subject from participating in the study or from using the proposed
             medication

          7. Negative urinary pregnancy test at the initial visit for women of childbearing
             potential

          8. Use of an effective contraceptive method (oral or injectable contraception,
             abstinence, intrauterine device, diaphragm, hysterectomy or bilateral ovariectomy,
             tubal attachment, condom, sponge, spermicide or partner with vasectomy) throughout the
             study for women of childbearing potential

          9. Subjects must agree not to undergo other dermatological or aesthetic treatments during
             the study period *The Minor test must be the last test to be done. Only the subjects
             who fulfill all the inclusion criteria above undergo the Minor test to check for
             sweating in the frontal region. The graduation considered positive for inclusion in
             the study will be 3 to 5.

        Inclusion Criteria:

          1. Pregnancy or intention to become pregnant during the study period

          2. Breastfeeding

          3. Botulinum toxin treatments in the last 6 months

          4. Subjects participating in other clinical studies

          5. Any surgical procedure performed that has affected the frontal or orbicularis muscle,
             previous blepharoplasty or eyebrow raising

          6. Any cosmetic procedures, including fillers, or scars that may interfere with the
             results of the study

          7. Fronto-parietal alopecia according to the Norwood-Hamilton classification

          8. Neoplastic, muscular or neurological diseases

          9. Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel
             blockers or that they will use at any time during the study

         10. Inflammatory or infectious processes at the application site

         11. Evident facial asymmetry

         12. History of adverse event, such as sensitivity to the components of the formula, ptosis
             or any other adverse event that, in the investigator's opinion, prevents the research
             subject from participating in the study

         13. Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease

         14. Coagulation disorders or use of anticoagulants

         15. Autoimmune disease

         16. History of poor adherence to treatments or who have shown lack of cooperation to
             adhere to the study protocol

         17. Any condition that, in the investigator's opinion, could compromise the results of the
             study