A Prospective, Split-Face, Randomized, Double-Blind Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles.
BACKGROUND
The authors sought to compare the newest U.S. Food and Drug Administration-approved botulinum toxin type A product, incobotulinumtoxinA, to onabotulinumtoxinA for upper face wrinkles. This is the first prospective, split-face, randomized, double-blind study addressing three types of facial wrinkles using a 1:1 dose ratio.


METHODS
The study was designed, institutional review board approval was obtained, and 45 patients were enrolled. A three-judge independent reviewer panel compared photographs of patients to the upper face validated assessment scales, selecting a grade ranging from 0 (no lines) to 4 (very severe) for the degree of glabellar lines, crow's feet, and forehead lines for each side of the face for photographs taken before treatment and 3 days, 2 weeks, 3 months, and 4 months after treatment. For toxin comparison, the difference in the magnitude of the degree of wrinkle scale at each period compared to before treatment was calculated and statistical analysis performed. Individual wrinkle types and all three wrinkle types combined were analyzed.


RESULTS
Both products offered significant reduction in individual and combined wrinkles at comparable time points; however, onabotulinumtoxinA had significantly greater combined dynamic wrinkle reduction at 3 days (p < 0.010), 2 weeks (p < 0.008), 3 months (p < 0.013), and 4 months (p < 0.045).


CONCLUSIONS
For identical dosage, both onabotulinumtoxinA and incobotulinumtoxinA are safe and effective in reducing dynamic wrinkles in the upper face; however, for the authors' dosages, onabotulinumtoxinA had statistically greater efficacy at 3 days, 2 weeks, 3 months, and 4 months.


METHODS
Therapeutic, II.
Winter Park and Sarasota, Fla. From YMD Eye & Face; and Center for Sight.
Ruth Hill
RH
Yeilding
John P
JP
Fezza
D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004311:Double-Blind Method; D005145:Face; D005152:Facial Muscles / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*
D065087:Acetylcholine Release Inhibitors; D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA