Comparison of Two Commercial Preparations of Botulinum Toxin Type A
Condition: Wrinkles in Frontal Area
Intervention: BOTULINUM TOXIN TYPE-A
Intervention description: On Visit 1 (Day 0):
Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
Dysport®: 4 units will be injected in the left or right forehead side.
Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Muscular activity; wrinkles in frontal area; action halos

Summary:

      The objective of this study is to compare the action halos of the botulinum toxins (Dysport®
      and Botox®) using two equivalence-ratios and to gather supportive information, such as more
      detailed data on the effectiveness in reduction of wrinkles and duration of action on the
      upper part of the face of both products, trough scales and photographs evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent (Annex 1)

          2. Female

          3. Subjects agreeing to take part in all procedures of the study, including botulinum
             toxin applications, Minor's test, measurement of Evoked Potentials, photographs,
             etc.), after being fully informed on the objectives and nature of the investigations

          4. Subjects aged between 18 and 60 years

          5. Subjects presenting with moderate to severe wrinkles on the forehead under maximum
             voluntary contraction of the m. frontalis

          6. Subjects with positive Minor's test showing sweating on the forehead in standardized
             conditions described in Annex 2

             *The Minor's Test will be the last inclusion criterion to be evaluated. Only these
             patients eligible according to the other inclusion criteria will undergo the Minor's
             Test to evaluate their sweating on the forehead. The cut off point is a positive
             Minor's Test (Level +1) - only subjects with Minor's Test (Level +1) will be recruited
             in the study (Annex 2).

          7. 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 products under
             investigation

          8. Subjects of childbearing age should present a negative urine pregnancy test at
             baseline and should be using an effective contraceptive method;

          9. Availability of the patient throughout the duration of the study (112 days)

         10. Subject agrees not to undergo other cosmetic or dermatological procedures during the
             study

         11. Subjects with sufficient schooling and awareness to enable them to cooperate to the
             degree required by this protocol

        Exclusion Criteria:

          1. Pregnant women or women intending to become pregnant in the next 4 months after
             screening for eligibility

          2. Subjects who are lactating

          3. Subjects having undergone botulinum toxin treatment within the last 6 months

          4. Subjects participating in other clinical trials

          5. Any prior surgery affecting the frontalis and/or orbicularis muscles, prior
             blepharoplasty or brow lift

          6. Any prior cosmetic procedures, including fillers, or scars that may interfere with the
             study results

          7. Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton
             classification

          8. Subjects with neoplastic, muscular or neurological diseases

          9. Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel
             blockers

         10. Subjects with inflammation or active infection in the area to be injected

         11. Subjects presenting evident facial asymmetry

         12. Subjects with a history of adverse effects, such as sensitivity to the components of
             the formula, ptosis or any other adverse effect, which in the investigator's opinion
             should prevent the patient from participating in the study

         13. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron
             diseases

         14. Subjects with coagulation disorders or using anticoagulants

         15. Subjects with known systemic autoimmune diseases

         16. Subjects with a history of medical treatment non-adherence or showing unwillingness to
             adhere to the study protocol

         17. Any condition that, in the opinion of the investigator, can compromise the evaluation
             of the study