Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Tox… (NCT01032954) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
Brazil90 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range30 Years – 60 Years
SexALL
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Inclusion criteria
✓. Written Informed Consent;
✓. Subjects aged between 30 and 60 years;
✓. Skin Fitzpatrick Phototypes I to VI;
✓. 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;
✓. Subjects presenting at least two indications for treatment with BT-A in each third of the face;
✓. 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;
✓. 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);
✓. Availability of the patient throughout the duration of the study (24 weeks);
Exclusion criteria
✕. Pregnant women or women intending to become pregnant during the study;
✕. Subjects participating in other clinical trials;
✕. Presence of scars on the face that may interfere with the result of study;
. Subjects with neoplastic, muscular or neurological diseases;
✕. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
✕. Subjects with inflammation or active infection in the face;
✕. Subjects with a history of sensitivity to the components of the formula;
✕. Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.