A Prospective, Split-Face, Randomized, Double-Blind Study Comparing
OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles.
Author(s): Yeilding RH(1), Fezza JP.
Affiliation(s): Author information:
(1)Winter Park and Sarasota, Fla. From YMD Eye & Face; and Center for Sight.
Publication date & source: 2015, Plast Reconstr Surg. , 135(5):1328-35
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.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
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