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drugset / Trial / NCT04949399

A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence

NCT04949399 ↗

Phase 3 Completed 408 enrolled AbbVie
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study in the United States and Canada. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.

Timeline

Start
2021-07-08
Primary completion
2022-12-20
Completion
2022-12-20

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs BOTOX; p <.0001; Difference (%) 30.4 (95% CI 23.5 to 37.2) NCT04949399 ↗

registry analysis (superiority test); Placebo vs BOTOX; p <0.0001; Difference (%) 39.8 (95% CI 32.0 to 47.7) NCT04949399 ↗

registry analysis (superiority test); Placebo vs BOTOX; p <0.0001; Difference (%) 41.6 (95% CI 33.7 to 49.6) NCT04949399 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic — Intramuscular

Indications

No indication recorded.