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

NCT05013424 | Completed Phase 2 Results FDA Drug

• 1 other identifier: M21-324
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Glabellar Lines

Keywords

Glabellar Lines; OnabotulinumtoxinA X; BOTOX

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1 to Day 180

Study Arms (3)

Formulation A: OnabotulinumtoxinA

EXPERIMENTAL

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

Drug: Formulation A: OnabotulinumtoxinA

Formulation B: OnabotulinumtoxinA

EXPERIMENTAL

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

Drug: Formulation B: OnabotulinumtoxinA

Formulation C: OnabotulinumtoxinA

EXPERIMENTAL

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

Drug: Formulation C: OnabotulinumtoxinA

Interventions

Formulation A: OnabotulinumtoxinA DRUG

Intramuscular Injection

Also known as: BOTOX, OnabotulinumtoxinA

Formulation A: OnabotulinumtoxinA

Formulation B: OnabotulinumtoxinA DRUG

Intramuscular Injection

Also known as: BOTOX

Formulation B: OnabotulinumtoxinA

Formulation C: OnabotulinumtoxinA DRUG

Intramuscular Injection

Also known as: BOTOX

Formulation C: OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Advanced Research Associates - Glendale /ID# 227368

Glendale, Arizona, 85308, United States

Location

Skin Research Institute LLC /ID# 227366

Coral Gables, Florida, 33146-1837, United States

Location

Etre Cosmetic Dermatology and Laser Center /ID# 227365

New Orleans, Louisiana, 70130-4353, United States

Location

The Center for Dermatology Cosmetics & Laser Surgery /ID# 227369

Mount Kisco, New York, 10549-3028, United States

Location

Austin Institute for Clinical Research /ID# 227367

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (5)