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

Glabellar Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100199
• Other study ID #: 2042-201-008
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: November 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• OnabotulinumtoxinA X
Injection
• Placebo
Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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