Completed

NCT Number: NCT05013424

A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL .

OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B & C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States.

Participants will receive one dose of OnabotA X administered as 5 injections on Day 1.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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Key information

Conditions

Glabellar Lines

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Research Associates - Glendale /ID# 227368, Glendale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.

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 OnabotA 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
Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator

Treatment and study plan

Formulation A: OnabotulinumtoxinA

Drug

Intramuscular Injection

Other names: BOTOX, OnabotulinumtoxinA

Formulation B: OnabotulinumtoxinA

Drug

Intramuscular Injection

Other names: BOTOX

Formulation C: OnabotulinumtoxinA

Drug

Intramuscular Injection

Other names: BOTOX

Primary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Day 1 to Day 180

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. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Phase 2a Multicenter Open-label Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X in Subjects With Glabellar Lines

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 19, 2021
Registry last updated: Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed