Full-face injections of variable total doses of abobotulinum toxin type A: a randomized, phase IV clinical trial of safety and efficacy
Hexsel, D.; Brum, C.; Porto, M.D.; Soirefmann, M.; Siega, C.; Schilling-Souza, J.; Rodrigues, T.C.
Journal of Drugs in Dermatology Jdd 12(12): 1356-1362
2013
ISSN/ISBN: 1545-9616 PMID: 24301236 Document Number: 12729
Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles on single or multiple facial areas. To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO). A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U. Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area. This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.
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