Clinical trial NCT05152576: A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
Official title: A Phase 2, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X for Forehead Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Forehead Lines
Keywords: Forehead Lines
OnabotulinumtoxinA X
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 124
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: Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.

Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.

Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.


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
* Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation

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.

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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Day 1 to Day 180
measure: Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
timeFrame: Day 1 to Day 180
measure: Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline on the investigator-rated clinician forehead lines Scale at maximum contraction.
timeFrame: Day 1 to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Assoc. Inc /ID# 239771
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 241512
state: California
city: Mount Kisco
country: United States
facility: The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester Inc. /ID# 239773
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Service /ID# 239779
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 239778
state: North Carolina
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 239777
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 239783
state: Texas
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: