Safety and Efficacy of TrenibotulinumtoxinE for Moderate-to-Severe Glabellar Lines: A Phase 2b, Double-Blind, Placebo-Controlled, Dose-Escalation Study.

Abstract

Glabellar lines (GLs) are facial furrows that can become aesthetically displeasing because of aging and repetitive muscle contractions. This dose-escalation study evaluated the safety and efficacy of trenibotulinumtoxinE for improving moderate-to-severe GL. Adult participants were randomized 3:1 in each of 5 dosage cohorts to receive trenibotulinumtoxinE or placebo as 5 intramuscular injections into the glabellar complex on Day 1, with in-clinic visits through Day 42. The primary endpoint was improvement response (≥2-grade investigator-rated improvement in Facial Wrinkle Scale at maximum frown) assessed cumulatively through Day 7. Treatment satisfaction was assessed by responses of very satisfied or mostly satisfied on Facial Line Satisfaction Questionnaire Items 4 and 5 at Hour 24 and Day 7. The primary objectives were met: all dosage cohorts showed greater efficacy for trenibotulinumtoxinE than placebo, as measured cumulatively through Day 7 (all P < .01, unadjusted). Improvements were seen among Cohort 5 (highest dosage) as early as 8 h postintervention (16.1%, noncumulative responder rate); by Hour 24, the responder rate was 41.9%, with peak efficacy (93.3%) at Day 7 and a decline to 33.3% by Day 14 through Day 42. Responder rates increased with dose (Cohort 1, 40.6%; Cohort 5, 96.8%). At Day 7, more Cohort 5 participants than placebo participants were satisfied with natural look and effect of treatment. No serious adverse events were reported. No events were consistent with local diffusion or distant spread of toxin. TrenibotulinumtoxinE was efficacious and well tolerated across a range of doses in treating moderate-to-severe GL. For image description, please refer to the figure legend and surrounding text.