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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Forehead Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo will be injected into the forehead on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intramuscular Injection

OnabotulinumtoxinA X Dose A

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA X

Intervention Type DRUG

Intramuscular Injection

OnabotulinumtoxinA X Dose B

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA X

Intervention Type DRUG

Intramuscular Injection

OnabotulinumtoxinA X Dose C

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA X

Intervention Type DRUG

Intramuscular Injection

Interventions

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OnabotulinumtoxinA X

Intramuscular Injection

Intervention Type DRUG

Placebo

Intramuscular Injection

Intervention Type DRUG

Other Intervention Names

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OnabotA X

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No