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

Allergan124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

124

Conditions

Forehead Lines

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

The Eye Research Foundation /ID# 241512

Newport Beach, California, United States

Steve Yoelin MD Medical Associate Inc /ID# 239771

Newport Beach, California, United States

The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776

Mount Kisco, New York, United States

Skin Search of Rochester Inc. /ID# 239773

Rochester, New York, United States

Dermatology Consulting Service /ID# 239779

High Point, North Carolina, United States

Wilmington Dermatology Center /ID# 239778

Wilmington, North Carolina, United States

Dallas Plastic Surgery Institute /ID# 239777

Dallas, Texas, United States

Duplicate_Austin Institute for Clinical Research /ID# 239783

Pflugerville, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Time frame: Day 1 to Day 180

Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters

Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.

Time frame: Day 1 to Day 180

Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.

Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.

Time frame: Day 1 to Day 30