A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Launched by ALLERGAN · Aug 13, 2021

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines.
• • Participant has severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.
• 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 OnabotA 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
• • History of facial nerve palsy
• • Infection or dermatological condition at the site of study drug injection
• • Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
• • Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator

Trial Officials