Clinical Trials

Date: 2018-09-14

Type of information: Results


Announcement: results

Company: Allergan (Ireland)

Product: Botox® (onabotulinumtoxinA)

Action mechanism: protein

Disease: moderate to severe glabellar lines

Therapeutic area: Aesthetic medicine


Trial details:

Latest news:

  • • On September 14, 2018, Allergan announced clinical study results of higher doses of Botox® Cosmetic compared to Botox® Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines. Allergan conducted this trial to evaluate the duration of effect and safety of Botox® Cosmetic 40, 60, and 80 unit doses versusBotox® Cosmetic 20 unit dose in patients with moderate to severe glabellar lines. The primary efficacy endpoint was met and was statistically significant for Botox® Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks (analysis, =1 point improvement in Facial Wrinkle Scale (FWS) from baseline assessed by Investigator at Maximum Frown).
  • In this trial, 32% of patients were responders at week 24 in the Botox® Cosmetic 40 unit group, 30.6% in theBotox® Cosmetic 60 unit group, and 38.5% in the Botox® Cosmetic 80 unit group as compared to 16% in the 20 unit group. The dose effect was observed across additional outcome variables.
  • For responders with a > 1 point improvement, the time to return to baseline also demonstrated a dose-effect. The median time on the Kaplan-Meier curve was 19.7 weeks for 20 Units and 24.0 weeks for 40 Units, suggesting the median benefit of 40 units is between 20 and 24 weeks.
  • The higher doses of Botox® Cosmetic were safe and well tolerated. In a total 233 patients evaluable for safety, there was one serious adverse event (SAE) unrelated to treatment. Overall treatment related adverse events (AEs) compare favorably with USPI labeled AEs and no new safety signals were identified. Across all studied doses there was 1 case (0.4%) eyelid ptosis at 80 unit and 1 case (0.4%) eyebrow ptosis at 20 unit.

Is general: Yes