A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

• Status: Recruiting
• Trial end date: 2022-11-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.

• Participant has moderate or severe GL at maximum frown.

Exclusion Criteria:

• History of known immunization to any botulinum toxin serotype.

• History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.

• Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:

• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

• Facial nerve palsy.

• Infection or dermatological condition at the site of study drug injection.