A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
Completed · Phase 3 · Has a placebo group
Conditions studied: Glabellar Frown Lines
In brief
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
Key facts
- Study ID
- NCT02334423
- Run by
- Evolus, Inc.
- People needed
- 330
- Starts
- 2015-01-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2019-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Steven Fagien, MD — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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