Results of a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a botulinum toxin type A topical gel for the treatment of moderate-to-severe lateral canthal lines.
BACKGROUND
Injections of botulinum toxin type A are commonly used to treat facial wrinkles; however, undesirable effects are associated with injections (e.g., pain, bruising, ptosis, immunogenicity, and needle aversion). To address these issues, RT001 Botulinum Toxin Type A Topical Gel is being developed for the treatment of lateral canthal lines.


OBJECTIVE
To assess the safety and efficacy of RT001 for the treatment of lateral canthal lines in a randomized, double-blind, placebo-controlled study.


METHODS
Adult subjects were enrolled to receive a single treatment of RT001 (n=45) or placebo (n=45) applied topically in the lateral canthal area. The primary endpoint was the composite of the Investigator Global Assessment of Lateral Canthal Line Severity (IGA-LCL) and the Patient Severity Assessment of lateral canthal line severity (PSA) defined as a 2-point or greater improvement on both scales.


RESULTS
At four weeks, 44.4 percent of subjects treated with RT001 achieved a 2-point or greater improvement on a rigorous composite of both the IGA-LCL and PSA scales compared to 0.0% for the placebo subjects (P<0.0001). At four weeks, 88.9 percent of subjects achieved clinically relevant improvement by investigator assessment. Adverse events were mild in severity and unrelated to study treatment.


CONCLUSIONS
RT001 appears to be a safe and well-tolerated treatment for improvement of lateral canthal lines.
University of California San Francisco, CA 94117, USA. rglogau@pacbell.net
Richard
R
Glogau
Andrew
A
Blitzer
Fredric
F
Brandt
Michael
M
Kane
Gary D
GD
Monheit
Jacob M
JM
Waugh
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D005143:Eyelids / Q000187:drug effects* / Q000473:pathology* / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D015595:Skin Aging / Q000187:drug effects* / Q000473:pathology* / Q000502:physiology; D016896:Treatment Outcome
D005782:Gels; D019274:Botulinum Toxins, Type A