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drugset / Trial / NCT04994535

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

NCT04994535 ↗

Phase 3 Completed 426 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 across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. 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
2021-08-10
Primary completion
2023-06-14
Completion
2023-06-14

Outcome

Met primary endpoint

registry NUMBER Placebo: 0.5 (NA to NA) percentage of participants NUMBER BOTOX: 31.4 (25.0 to 37.8) percentage of participants analysis (superiority test); Placebo vs BOTOX; p <.0001 NCT04994535 ↗

registry NUMBER Placebo: 2.2 (0 to 4.3) percentage of participants NUMBER BOTOX: 41.0 (33.8 to 48.3) percentage of participants analysis (superiority test); Placebo vs BOTOX; p <0.0001 NCT04994535 ↗

registry NUMBER Placebo: 3.9 (1.1 to 6.7) percentage of participants NUMBER BOTOX: 40.8 (33.5 to 48.1) percentage of participants analysis (superiority test); Placebo vs BOTOX; p <0.0001 NCT04994535 ↗

Drugs

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

Indications

No indication recorded.