A pilot study on the effect of epinephrine on botulinum toxin treatment for periorbital rhytides

Relaxation of hyperactive facial muscles by injection of botulinum toxin type A (BOTOX, Allergan Inc., Irvine, CA) represents the most common cosmetic procedure performed in the United States.

The objective of this split-face randomized double-blind study was to determine the effect of epinephrine (EPI) on the efficacy of BOTOX treatment of muscle hyperactivity in the upper face.

Fourteen subjects (ages 39-57 years) with moderate to severe periorbital rhytides were enrolled. Study patients were blinded to the two treatment arms, BOTOX and BOTOX plus EPI 1:100,000. Subjective and objective evaluations were performed at 0 and 4 days and 1, 3, and 6 months, and clinical improvement was assessed using a nominal scale from 0 to 4, corresponding to 0, 1% to 25%, 26% to 50%, 51% to 75%, and 76% to 100% improvement, respectively. The incidence of adverse events was also recorded. RESULTS Fourteen subjects with moderate to severe periorbital rhytides were treated with BOTOX or BOTOX plus EPI. One subject was discontinued from the study after receiving asymmetric doses of BOTOX. At 4, 30, and 90 days after treatment, subjective and objective improvement scores revealed that EPI enhanced the efficacy of BOTOX when compared to BOTOX alone. By 3 months, the effect of BOTOX and BOTOX plus EPI had peaked and continued to fall through 6 months. One of 14 patients did not appear to respond to BOTOX treatment. Both treatments were well tolerated with no serious adverse events.

To our knowledge, we are the first to test under randomized double-blind conditions the effect of EPI on efficacy of BOTOX. Our data suggest that addition of EPI may accelerate the rate of onset as well as the short-term efficacy of BOTOX for treatment of periorbital rhytides.