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

Completed · Phase 2 · Has a placebo group

Conditions studied: Glabellar Lines

In brief

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.

Key facts

Study ID

NCT05100199

Run by

Allergan

People needed

328

Starts

2021-10-06

Expected to finish

2022-12-02

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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, in the opinion of the investigator.
• Participant has moderate or severe GL at maximum frown.

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 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.

Where it is running

• Advanced Research Associates - Glendale /ID# 230418 — Glendale, Arizona, United States
• Westside Aesthetics /ID# 230305 — Los Angeles, California, United States
• The Eye Research Foundation /ID# 232544 — Newport Beach, California, United States
• The Research Center at The Maas Clinic /ID# 230685 — San Francisco, California, United States
• Center for Dermatology and Dermatologic Surgery /ID# 230684 — Washington D.C., District of Columbia, United States
• Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542 — Boca Raton, Florida, United States
• Baumann Cosmetic and Research Institute /ID# 232545 — Miami, Florida, United States
• Research Institute of the Southeast, LLC /ID# 230436 — West Palm Beach, Florida, United States
• Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693 — Metairie, Louisiana, United States
• Etre Cosmetic Dermatology and Laser Center /ID# 230437 — New Orleans, Louisiana, United States
• SLUCare Cosmetic Dermatology /ID# 230333 — St Louis, Missouri, United States
• Laser & Skin Surgery Center of New York /ID# 230683 — New York, New York, United States
• Skin Search of Rochester Inc. /ID# 242540 — Rochester, New York, United States
• Aesthetic Solutions /ID# 230716 — Chapel Hill, North Carolina, United States
• Wilmington Dermatology Center /ID# 242544 — Wilmington, North Carolina, United States
• Aventiv Research Dublin /ID# 232546 — Dublin, Ohio, United States
• Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543 — Austin, Texas, United States
• Premier Clinical Research /ID# 230682 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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