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

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ClinicalTrials.gov Identifier: NCT02184988
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : February 5, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Evolus, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: Botulinum purified neurotoxin, Type A Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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




Primary Outcome Measures :
  1. The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year [ Time Frame: 365 Days ]
    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.


Other Outcome Measures:
  1. 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) [ Time Frame: 365 Days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184988


Locations
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United States, California
ATS Clinical Research
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Evolus, Inc.
Investigators
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Study Director: Rui Avelar, MD Evolus, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evolus, Inc.
ClinicalTrials.gov Identifier: NCT02184988     History of Changes
Other Study ID Numbers: Evolus - CLIN004
First Posted: July 9, 2014    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Analysis will be of combined data for all subjects entered into the study
Keywords provided by Evolus, Inc.:
Glabellar Lines
Botulinum purifies neurotoxin, Type A (DWP-450)
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents