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Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 (EV-006)

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ClinicalTrials.gov Identifier: NCT02428608
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Evolus, Inc.

Brief Summary:
The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: DWP-450 (Botulinum purified neurotoxin, Type A) Phase 2

Detailed Description:

Up to five hundred and thirty (530) subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.

Subjects with moderate-to-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.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This is an open label safety study
Primary Purpose: Treatment
Official Title: A Multi-center, Open Label, Single 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 : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botulinum toxin, Tyoe A
DWP-450 (Botulinum toxin, Type A)
Biological: DWP-450 (Botulinum purified neurotoxin, Type A)
Botulinum toxin, Type A
Other Name: DWP-450




Primary Outcome Measures :
  1. Safety (adverse reactions) [ Time Frame: 365 days ]
    Safety will be evaluated by incidence, severity and duration of any adverse reactions during the study period.


Secondary Outcome Measures :
  1. Exploratory Efficacy (Global Aesthetic Improvement Score) [ Time Frame: 365 days ]
    The by subject and investigator assessment will be measured at defined time points over the course of the study and summarized.

  2. Exploratory Efficacy (Subject Satisfaction will be measured using the Subject Satisfaction Scale) [ Time Frame: 365 days ]
    At defined time points, Subject Satisfaction will be measured using the Subject Satisfaction Scale and summarized.



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:

  • Subjects must be an adult 18 years of age and 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 and 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)
  • 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, nursing 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): NCT02428608


Locations
United States, Nebraska
The Advanced Skin Research Center at Skin Specialists, PC
Omaha, Nebraska, United States, 68144
Sponsors and Collaborators
Evolus, Inc.
PPD
Investigators
Study Director: Rui Avelar, MD Evolus, Inc.

Responsible Party: Evolus, Inc.
ClinicalTrials.gov Identifier: NCT02428608     History of Changes
Other Study ID Numbers: Evolus - CLIN006
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Developing a plan

Keywords provided by Evolus, Inc.:
Glabellar Lines
Botulinum toxin, Type A

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents