A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines

Allergan

Status and phase: Completed; Phase 2

Conditions: Forehead Lines

Treatments: Drug: OnabotulinumtoxinA X; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05152576

M21-606

Details and patient eligibility

About

Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.

Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.

Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Enrollment: 124 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
• Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation

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.

• History of 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: Triple Blind

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124 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo will be injected into the forehead on Day 1.

Treatment:

Drug: Placebo

OnabotulinumtoxinA X Dose A

Experimental group

Description:

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose B

Experimental group

Description:

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose C

Experimental group

Description:

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Treatment:

Drug: OnabotulinumtoxinA X