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

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

NCT05100199

Glabellar Lines

COMPLETED PHASE2

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

NCT05152576

Forehead Lines

COMPLETED PHASE2

A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines

NCT05496335

Glabellar Lines

COMPLETED PHASE1

A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

NCT02261467

Forehead Rhytides Glabellar Rhytides

COMPLETED PHASE3

A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

NCT06583486

Moderate to Severe Glabellar Lines

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glabellar Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Formulation A: OnabotulinumtoxinA

Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.

Group Type EXPERIMENTAL

Formulation A: OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injection

Formulation B: OnabotulinumtoxinA

Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.

Group Type EXPERIMENTAL

Formulation B: OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injection

Formulation C: OnabotulinumtoxinA

Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.

Group Type EXPERIMENTAL

Formulation C: OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Formulation A: OnabotulinumtoxinA

Intramuscular Injection

Intervention Type DRUG

Formulation B: OnabotulinumtoxinA

Intramuscular Injection

Intervention Type DRUG

Formulation C: OnabotulinumtoxinA

Intramuscular Injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX OnabotulinumtoxinA BOTOX BOTOX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No