Phase 3
N=330
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT02334423 ↗Enrolled (actual)
330
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject — 67.5; 1.2 percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin, Type A (Biological); 0.9% sterile, unpreserved saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Evolus, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject |
26.5; 1.3 | — |
| SECONDARY Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject |
26.5; 1.3 | — |
| SECONDARY Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject |
26.5; 1.3 | — |
| SECONDARY Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject |
26.5; 1.3 | — |
Summary
The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects
Eligibility Criteria
Inclusion Criteria
- Subjects is an adult, of at least 18 years of age
- Subject is able to provide informed consent and comply with study instructions
- Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS
- Subject has moderate to severe glabellar lines at maximum frown as assessed by the subject using the GLS
- Subject is willing and able to complete the entire course of the study
Exclusion Criteria
- Previous treatment with botulinum toxin of any serotype in any area within the last 6 months
- Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
- Previous insertion of permanent material in the glabellar area
- Planned treatment with botulinum toxin of any serotype in any other body region during the study period
- 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 eye brow)
- Energy-based or cryo-therapy 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 (subjects can continue with their usual skin care routine)
- Subjects who may not respond to 20 Units of botulinum toxin (e.g., inability to substantially lessen glabellar frown lines even by physically spreading them apart)
- Marked facial asymmetry
- 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
- Any active infection in the area of the injection sites
- Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
- Evidence of recent alcohol or drug abuse
- 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
- Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
- Known allergy or hypersensitivity to botulinum toxin preparation
- Participation in another interventional clinical study within the last 30 days
Data sourced from ClinicalTrials.gov (NCT02334423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.