Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05320393
Other study ID # EVOLUS-CLIN201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 30, 2022
Est. completion date May 22, 2023

Study information

Verified date May 2023
Source Evolus, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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®).


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date May 22, 2023
Est. primary completion date May 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Outpatient, male or female of any race, 18 years of age or older. - Female subjects of childbearing potential must have a negative UPT during Visits 1 (Screening) and 2 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 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 IRB-approved 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PrabotulinumtoxinA-Xvfs
One treatment of 40 units
OnabotulinumtoxinA
One treatment of 20 units
PrabotulinumtoxinA-Xvfs
One treatment of 20 units

Locations

Country Name City State
United States Aesthetic Eyelid Plastic Surgery Boca Raton Florida

Sponsors (2)

Lead Sponsor Collaborator
Evolus, Inc. ethica Clinical Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Effect Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units 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.
See also
  Status Clinical Trial Phase
Completed NCT02236312 - Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines Phase 2
Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Completed NCT00430963 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines Phase 3
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT05623410 - Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines Phase 3
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Completed NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Completed NCT04143815 - Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3
Completed NCT01333397 - Safety and Efficacy Study of Dysport RU and Glabellar Lines Phase 2