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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines

This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: Placebo; Drug: OnabotulinumtoxinA X

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates - Glendale /ID# 230418
  • California
    • Los Angeles, California, United States, 90025-1708
      • Westside Aesthetics /ID# 230305
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 232544
    • San Francisco, California, United States, 94115-1809
      • The Research Center at The Maas Clinic /ID# 230685
  • District of Columbia
    • Washington, District of Columbia, United States, 20037-1445
      • Center for Dermatology and Dermatologic Surgery /ID# 230684
  • Florida
    • Boca Raton, Florida, United States, 33431-6465
      • Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
    • Miami, Florida, United States, 33137-3254
      • Baumann Cosmetic and Research Institute /ID# 232545
    • West Palm Beach, Florida, United States, 33401-2712
      • Research Institute of the Southeast, LLC /ID# 230436
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
    • New Orleans, Louisiana, United States, 70130-4353
      • Etre Cosmetic Dermatology and Laser Center /ID# 230437
  • Missouri
    • Saint Louis, Missouri, United States, 63122-3379
      • SLUCare Cosmetic Dermatology /ID# 230333
  • New York
    • New York, New York, United States, 10016-4974
      • Laser & Skin Surgery Center of New York /ID# 230683
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester Inc. /ID# 242540
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517-9901
      • Aesthetic Solutions /ID# 230716
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center /ID# 242544
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Dublin /ID# 232546
  • Texas
    • Austin, Texas, United States, 78746-4720
      • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 230682

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
• Participant has moderate or severe GL at maximum frown.

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.
• Facial nerve palsy.
• Infection or dermatological condition at the site of study drug injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo will be injected into the Glabellar Complex on Day 1.	Drug: Placebo; Injection
Experimental: OnabotulinumtoxinA X Dose A; OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X; Injection
Experimental: OnabotulinumtoxinA X Dose B; OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X; Injection
Experimental: OnabotulinumtoxinA X Dose C; OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.	Drug: OnabotulinumtoxinA X; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale.	The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe	Day 1 to Day 30
Percentage of Participants With Adverse Events (AEs)	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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of 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 study drug.	Day 1 to Day 270

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale.	The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe	Day 1 to Day 30
Percentage of Participants with Achievement of improvement per the Facial Lines Satisfaction Questionnaire Impact domain, among subjects with baseline scores of 14 points or greater.	The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.	Day 1 to Day 30
Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5.	The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.	Day 1 to Day 60

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Glabellar Lines; BOTOX; OnabotulinumtoxinA X
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2042-201-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No