A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines.
BACKGROUND
IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL.


OBJECTIVE
To investigate the dose equivalence of incobotulinumtoxinA (20 U) and onabotulinumtoxinA (20 U) for the treatment of moderate-to-severe GFL.


METHODS
Prospective, randomized (1:1), double-blinded, parallel-group study in 250 females (18-50 years), employing a single treatment with incobotulinumtoxinA or onabotulinumtoxinA, followed by a 4-month observational period.


RESULTS
At the primary efficacy endpoint (1 month after treatment), incobotulinumtoxinA was equivalent to onabotulinumtoxinA in the treatment of GFL at the 20 U dose within the prespecified ± 15% margin of equivalence. Efficacy remained similar between treatment groups through 4 months after treatment as assessed by the independent masked panel and the masked treating physicians. Patient satisfaction ratings were similar between groups and favorable (>90%) throughout. Both treatments were well tolerated.


CONCLUSIONS
Equivalence was demonstrated at the primary endpoint between incobotulinumtoxinA and onabotulinumtoxinA in the treatment of GFL at the 20 U dose at 1 month. Similar efficacy and tolerability profiles were observed through 4 months after treatment.
*Manhattan Eye, Ear & Throat Hospital, New York, New York; †Tennessee Clinical Research Center, Nashville, Tennessee; ‡Tulane Health Sciences Center, New Orleans, Louisiana; §Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; ‖Center for Dermatology and Laser Surgery, Sacramento, California; ¶Washington Institute of Dermatologic Laser Surgery, Georgetown University Hospital, Washington, DC; #Skin Care Physicians, Chestnut Hill, Massachusetts; **Center for Dermatology and Dermatologic Surgery, Washington, DC; ††University of California Los Angeles, Los Angeles, California; ‡‡Complete Medical Communications, Macclesfield, United Kingdom.
Michael A C
MA
Kane
Michael H
MH
Gold
William P
WP
Coleman
Derek H
DH
Jones
Emil A
EA
Tanghetti
Tina S
TS
Alster
Tom E
TE
Rohrer
Cheryl M
CM
Burgess
Ava T
AT
Shamban
Eleanor
E
Finn
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005152:Facial Muscles / Q000187:drug effects*; D005260:Female; D005546:Forehead; D006801:Humans; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D017060:Patient Satisfaction; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA