drugset / Trial / NCT06218251

A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

NCT06218251 ↗

Phase 4 Completed 100 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

Summary

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.

Timeline

Start
2024-02-05
Primary completion
2024-07-25
Completion
2024-12-17

Drugs

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

Indications

No indication recorded.