A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

Launched by ABBVIE · Feb 14, 2025

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ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of two treatments for reducing the appearance of moderate to severe glabellar lines, which are the wrinkles that form between the eyebrows when you frown. The trial is specifically comparing a new treatment called AGN-151586 with OnabotulinumtoxinA, a well-known treatment for these wrinkles. Researchers want to see how well these treatments work and if there are any side effects.

To participate in this trial, you need to be between the ages of 65 and 74 and have moderate to severe glabellar lines as determined by both you and the study doctor. You should also be in good overall health. However, if you have an active skin infection where the injections would be given, or if you have had specific allergic reactions to similar treatments, you wouldn’t be eligible. If you join the study, you can expect to receive one of the treatments and will be closely monitored for any side effects or changes in your condition. This research will help better understand these treatments for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
• • Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.
• Exclusion Criteria:
• • Active infection or dermatological condition at the treatment injection sites.
• • History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.