Comparison of Two Commercial Preparations of Botulinum Toxin Type A (NCT00959907) | Clinical Trial Compass
CompletedPhase 4
Comparison of Two Commercial Preparations of Botulinum Toxin Type A
Brazil29 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Written Informed Consent (Annex 1)
✓. Female
✓. 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
✓. Subjects aged between 18 and 60 years
✓. Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
✓. Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2
✓. 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
✓. Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
Exclusion criteria
✕. Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
✕. Subjects who are lactating
✕. Subjects having undergone botulinum toxin treatment within the last 6 months