Efficacy and safety evaluation of a novel botulinum toxin topical gel for the treatment of moderate to severe lateral canthal lines.
BACKGROUND
Botulinum toxin type A (BoNTA) is commonly injected to treat facial wrinkles. Complications include pain, erythema, bruising, and potential infection. RT001 Botulinum Toxin Type A Topical Gel (RT001) is under development for the treatment of lateral canthal lines (LCLs).


OBJECTIVE
To assess the efficacy and safety of RT001 for the treatment of LCLs using a randomized, double-blind, repeat-dose, placebo-controlled study design.


METHODS
Healthy adult subjects were randomized to receive RT001 (N=19) or placebo (N=17) applied to their lateral canthal areas (LCAs). To evaluate safety of repeat exposure, treatment was administered at baseline and week 4. The primary efficacy measure was improvement in baseline LCL severity using the Investigator's Global Assessment of Lateral Canthal Line at Rest (IGA-LCL) Severity Scale.


RESULTS
At 8 weeks, 19 (50%) LCAs treated with RT001 showed a 2-point or greater improvement in baseline IGA-LCL severity, versus none (0%) of the placebo-treated subjects (p<.001); 36 (94.7%) LCAs treated with RT001 showed a 1-point or more improvement in baseline IGA-LCL severity, versus five (14.7%) placebo-treated LCAs (p<.001). There were no treatment-related adverse events.


CONCLUSIONS
RT001 was well tolerated and demonstrated an improvement in LCLs.
Dermatology Research Institute, LLC, Coral Gables, Florida, USA. acazzaniga@drinstitute.org
Fredric
F
Brandt
Christopher
C
O'Connell
Alex
A
Cazzaniga
Jacob M
JM
Waugh
D000287:Administration, Topical; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004311:Double-Blind Method; D005123:Eye; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D005782:Gels; D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A