Status:
COMPLETED
Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
Lead Sponsor:
Evolus, Inc.
Collaborating Sponsors:
ethica Clinical Research Inc.
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 seve...
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 U...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05320393
Start Date
March 30 2022
End Date
May 22 2023
Last Update
September 4 2024
Active Locations (1)
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1
Aesthetic Eyelid Plastic Surgery
Boca Raton, Florida, United States, 33431