Greater satisfaction reported in Botox vs. placebo for crow's feet, glabellar lines

CHICAGO — Patients treated with onabotulinumtoxinA reported significantly greater satisfaction and psychological improvement in perceived impact of crow’s feet and glabellar lines compared with those treated with placebo, according to research presented at the American Society for Dermatologic Surgery annual meeting.

“Botox treats crow’s feet lines beautifully, and we were able to prove that in two very large, randomized, well-controlled clinical studies,” researcher Elisabeth Lee, MPH, Allergan’s director of clinical development, dermatology therapeutic area, told Healio.com.

“In addition, in our second study,” she said, “we had a treatment group where both crow’s feet and glabellar lines [GL] were treated together. We saw not only positive results with 24 units, but also in that group treated for both together [with 44U] … [we had] even statistically significantly greater [results] than the positive results in the first group.”

Researchers used patient-reported results from the Facial Line Outcomes (FLO-11) questionnaire and Subject Assessment of Satisfaction of Appearance as efficacy measures at patients’ 30-day visits after a single treatment in the phase 3, double blind, placebo-controlled trials of onabotulinumtoxinA (Botox, Allergan) for treating crow’s feet lines (CFL).

Four hundred forty-five patients in study 1 were randomly assigned CFL treatment with 24U onabotulinumtoxin A or placebo. Nine hundred seventeen patients in study 2 were randomly assigned 24U onabotulinumtoxinA (CFL only), 44U (CFL 24U plus 20U to GL) or placebo. FLO-11 items 2, 5 and 8— indicating “looking less tired,” “improvement in attractiveness” and “reduction in tired appearance,” respectively — determined psychological impact. Patients who achieved at least a 2-point improvement from baseline for items 2 and 5 and at least a 3-point improvement for item 8 were considered responders.

About 50% of patients in study 1 and 36% in study 2 had moderate or severe CFL at maximum smile. Significantly greater improvement was reported by the 24U group compared with placebo-treated patients for item 2 (70% vs. 28%), item 5 (66.8% vs. 22.8%) and item 8 (55.8% vs. 16.3%, P<.001, all comparisons). Responder rates (RRs) in study 2 in the 24U and 44U onbotulinumtoxinA treatment groups compared with placebo, respectively, were: item 2, 54.4%, 69.9% vs. 24.6%; item 5, 48.6%, 61.7% vs. 18.6%; and item 8, 40.7%, 58.% vs. 14.9% (P<.001, all comparisons vs. placebo).

Treatment satisfaction RRs in study 1 were 60.1% for the treated group vs. 7.5% for the placebo group (P<.001). RRs were 48.5% and 58.2% for the onabotulinumtoxinA 24U and 44U treatment groups in study 2, compared with 7.8% for placebo patients (P<.001, all comparisons). Treatment satisfaction levels and the three FLO-11 item scores were significantly greater in the 44U group compared with the 24U group in study 2.

For more information:

Effects of OnabotulinumtoxinA-Purified Neurotoxin Complex Treatment for Crow’s Feet Lines on Patient-Reported Outcomes: Psychological Impact and Patient Satisfaction. Presented at: American Society for Dermatologic Surgery 2013 Annual Meeting; Oct 3-6, Chicago.

Disclosure: William P. Coleman III, MD, serves as a consultant for Miramar, Merz, Allergan, Cabachon, Anterios, Ultrashape and Contura. Koen DeBoulle, MD, serves as a consultant for Allergan. Elisabeth Lee, MPH, is employed by Allergan.