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

Completed · Phase 2 · Has a placebo group

Conditions studied: Forehead Lines

In brief

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.

Key facts

Study ID

NCT05152576

Run by

Allergan

People needed

124

Starts

2021-11-29

Expected to finish

2022-09-06

Last updated by the study team

2025-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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