Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines (EV-004)

Evolus

Status and phase

Completed

Phase 2

Conditions

Glabellar Frown Lines

Treatments

Biological: Botulinum purified neurotoxin, Type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02184988

Evolus - CLIN004

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.

Full description

Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.

Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment.

Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.

Enrollment

352 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study):

Subjects must be an adult 18 years of age or over
Subject is able to provide informed consent and comply with study instructions
Subject has moderate to severe glabellar lines on maximum frown as assessed by the investigator using the GLS
Subject is willing and able to complete the entire course of the study

Exclusion Criteria (A subject must not meet the following exclusion criteria in order to be eligible for enrollment in the stud)y:

Previous treatment with botulinum toxin of any serotype in the forehead area within the last 8 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)
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