Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 737 for:    Botulinum Toxins, Type A
Previous Study | Return to List | Next Study

A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002 (EV-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02334436
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : February 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Evolus, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: Botulinum toxin, Type A Other: 0.9% sterile, unpreserved saline Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized, Double Blind, Placebo-controlled, Single Dose, Trial to Demonstrate the Safety and Efficacy of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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

Placebo Comparator: Placebo
0.9% sterile, unpreserved saline
Other: 0.9% sterile, unpreserved saline
Placebo Comparator Arm




Primary Outcome Measures :
  1. Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject [ Time Frame: Day 30 ]

    The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30.

    GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.



Secondary Outcome Measures :
  1. Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject [ Time Frame: 90 Days ]

    Secondary endpoint was the proportion of subjects classified as responders on Day 90. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 90 Day.

    GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.


  2. Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject [ Time Frame: Day 120 ]

    Secondary endpoint was the proportion of subjects classified as responders on Day 120. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 120 Day

    GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.


  3. Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject [ Time Frame: Day 150 ]

    Secondary endpoint was the proportion of subjects classified as responders on Day 150. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 150 Day

    GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT02334436


Locations
Layout table for location information
United States, California
The Clinical Testing Center of Beverly Hills
Beverly Hills, California, United States, 90210
Sponsors and Collaborators
Evolus, Inc.
PPD
Investigators
Layout table for investigator information
Study Director: Rui Avelar, MD Evolus, iInc.

Layout table for additonal information
Responsible Party: Evolus, Inc.
ClinicalTrials.gov Identifier: NCT02334436     History of Changes
Other Study ID Numbers: EV-002
First Posted: January 8, 2015    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Botulinum Toxins
Botulinum Toxins, Type A
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