Clinical trial NCT05100199: A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Lines
Keywords: OnabotulinumtoxinA X
BOTOX
Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale.
timeFrame: Day 1 to Day 30
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Day 1 to Day 270
Secondary outcomes:
measure: Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale.
timeFrame: Day 1 to Day 30
measure: 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.
timeFrame: Day 1 to Day 30
measure: Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5.
timeFrame: Day 1 to Day 60
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 230418
state: Arizona
city: Los Angeles
country: United States
facility: Westside Aesthetics /ID# 230305
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 232544
state: California
city: San Francisco
country: United States
facility: The Research Center at The Maas Clinic /ID# 230685
state: California
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery /ID# 230684
state: District of Columbia
city: Boca Raton
country: United States
facility: Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute /ID# 232545
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC /ID# 230436
state: Florida
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
state: Louisiana
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center /ID# 230437
state: Louisiana
city: Saint Louis
country: United States
facility: SLUCare Cosmetic Dermatology /ID# 230333
state: Missouri
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 230683
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester Inc. /ID# 242540
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 230716
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 242544
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Dublin /ID# 232546
state: Ohio
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 230682
state: Washington
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: