Phase 2 N=124 Randomized Triple-blind Treatment

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

Forehead Lines

Bottom Line

View on ClinicalTrials.gov: NCT05152576 ↗

Enrolled (actual)

124

Serious AEs

0.8%

Results posted

Jul 2025

Primary outcome: Primary: Number of Participants With Adverse Events — 10; 12; 18; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OnabotulinumtoxinA X (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	10; 12; 18; 13	—
PRIMARY Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters	0; 1; 1; 1; 0; 1	—
PRIMARY Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.	58.6; 100; 96.8; 100	<0.001 sig

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05152576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.