Clinical trial NCT05320393: Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
Official title: Phase II Multi-Ctr, Prospective, Randomized, Double Blind, Active-Controlled Single Treatment Increasing Dose Trial to Study Safety & Duration of Effect of 40U of PrabotulinumtoxinA-xvfs in Adult Subjects for Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Keywords: Botulinum toxin type A
Lead sponsor: Evolus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2022-04-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and duration of effect of 40 Units of prabotulinumtoxinA-xvfs (Jeuveau®) in providing temporary improvement in the appearance of moderate to severe glabellar lines (frown lines, which are the vertical lines that develop between the eyebrows) in adult participants. It will also determine if the duration of effect of 40 Units of Jeuveau® is greater than that of 20 Units of Jeuveau® and 20 Units of Botox® Cosmetic.

Detailed description: This is a multicenter, prospective, randomized, double-blind, active-controlled, single-treatment, increasing dose design. Up to one hundred and fifty subjects will be randomized 1:1:1, to either 20 Units onabotulinumtoxinA (Botox® Cosmetic), 20 Units prabotulinumtoxinA-xvfs (Jeuveau®), or 40 Units prabotulinumtoxinA-xvfs (Jeuveau®).

Eligibility criteria: Inclusion Criteria:

* Outpatient, male or female of any race, 18 years of age or older.
* Female subjects of childbearing potential must have a negative urine pregnancy test during Visits 1 (Screening) and Visit 2 (if applicable) and practice a reliable method of contraception for the duration of the study.
* Moderate to severe glabellar lines (i.e., score of 2 or 3) on maximum frown as assessed by the investigator using the Glabellar Line Scale (GLS).
* Subject has moderate to severe glabellar lines (i.e., score of 2 or 3) at maximum frown as assessed by the subject using the GLS.
* Able to follow study instructions and likely to complete all required visits.
* Sign the Institutional Review Board (IRB) -approved Informed Consent Form (ICF) prior to any study-related procedures being performed.

Exclusion Criteria:

* Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
* Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (IP) or control.
* Any active infection in the area of the injection sites.
* Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
* Marked facial asymmetry (Investigator discretion).
* Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis.
* History of facial nerve palsy.
* Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin (Investigator discretion).
* Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
* Previous treatment with botulinum toxin of any serotype above the level of the lateral canthus within the last 6 months.
* Planned treatment with botulinum toxin of any serotype below the level of the lateral canthus during the study period.
* Previous treatment with any facial aesthetic procedure (e.g., injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months.
* Previous insertion of permanent material in the glabellar area.
* Any previous energy based or cryotherapy-based treatment of facial muscles superior to the lateral canthus.
* Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (can continue with their usual skin care routine).
* Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles, or a combination of these, or scars in the glabellar area and the surrounding areas (including eyebrow).
* Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
* Evidence of recent alcohol or drug abuse (Investigator discretion).
* History of poor cooperation or unreliability.
* Planning to move out of the area prior to study completion.
* Subjects who are investigational site staff members or family members of such employees.
* Exposure to any other investigational drug/device within 30 days prior to Visit 1.

Primary outcomes:
measure: Duration of Effect Described by Kaplan-Meier Analysis
timeFrame: Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Aesthetic Eyelid Plastic Surgery
state: Florida
Study officials:
affiliation: Evolus, Inc.
name: Rui Avelar, MD
role: STUDY_DIRECTOR
References: