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

Allergan

Status and phase: Completed; Phase 2

Conditions: Glabellar Lines

Treatments: Drug: Placebo; Drug: OnabotulinumtoxinA X

Study type: Interventional

Funder types: Industry

Identifiers

NCT05100199

2042-201-008

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo will be injected into the Glabellar Complex on Day 1.

Treatment:

Drug: Placebo

OnabotulinumtoxinA X Dose A

Experimental group

Description:

OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose B

Experimental group

Description:

OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose C

Experimental group

Description:

OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X