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

A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: Botulinum purified neurotoxin, Type A

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • ATS Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Botulinum neurotoxin, Type A; DWP-450 (Botulinum purified neurotoxin, Type A) Injection

Biological: Botulinum purified neurotoxin, Type A; The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.; Other Names: DWP-450 (Botulinum purified neurotoxin, Type A) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year	The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.	365 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS)	GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS	365 Days

Collaborators and Investigators

• Sponsor: Evolus, Inc.
• Investigators: Study Director: Rui Avelar, MD, Evolus, Inc.

Publications and helpful links

General Publications

• Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci. 2015 Oct 15;357(1-2):192-7. doi: 10.1016/j.jns.2015.07.028. Epub 2015 Jul 21.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Glabellar Lines; Botulinum purifies neurotoxin, Type A (DWP-450)
• Other Study ID Numbers: Evolus - CLIN004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Analysis will be of combined data for all subjects entered into the study