A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
Status:
Recruiting
Trial end date:
2022-06-13
Target enrollment:
Participant gender:
Summary
Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar
lines (GL), are typically treated by selectively weakening specific muscles with small
quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic
treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in
aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X
formulation is in treating adult participants with GL .
OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment
of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the
safety of OnabotA X in adult subjects with moderate to severe GL. Around 90 participants will
be enrolled in the study in approximately 5 sites in the United States.
Participants will receive one dose of OnabotA X administered as 5 injections on Day 1.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular weekly visits during the study at a
hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.