A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001

Evolus

Status and phase

Completed

Phase 3

Conditions

Glabellar Frown Lines

Treatments

Biological: Botulinum toxin, Type A

Other: 0.9% sterile, unpreserved saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT02334423

EV-001

Details and patient eligibility

About

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

Full description

Three hundred and twenty-four eligible subjects will be randomly assigned 3:1 to receive DWP-450 or placebo. Safety and efficacy will be assessed on Days 2, 7, 14, 30, 90, 120 and 150. The primary efficacy end point assesses the effectiveness of the DWP-450 against placebo on Day 30 in a superiority design.

Enrollment

330 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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