- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334436
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002 (EV-002)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90210
- The Clinical Testing Center of Beverly Hills
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botulinum toxin, Type A
|
Botulinum toxin, Type A
Other Names:
|
Placebo Comparator: Placebo
0.9% sterile, unpreserved saline
|
Placebo Comparator Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 120
|
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. |
Day 150
|
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. |
90 Days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glabellar Frown Lines
-
Pacira CryoTech, Inc., a wholly owned subsidiary...CompletedGlabellar Frown Lines | Frown LinesUnited States
-
Pacira CryoTech, Inc., a wholly owned subsidiary...CompletedGlabellar Frown Lines | Frown LinesUnited States
-
Galderma R&DCompletedGlabellar Frown Lines | Canthal LinesUnited States
-
ATGC Co., Ltd.RecruitingGlabellar Frown LinesKorea, Republic of
-
Medy-ToxCompletedGlabellar Frown LinesAustralia
-
Galderma R&DActive, not recruitingGlabellar Frown LinesUnited States
-
Galderma R&DCompletedGlabellar Frown LinesUnited States
-
Galderma R&DCompleted
-
Revance Therapeutics, Inc.CompletedEfficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesGlabellar Frown LinesUnited States
-
Revance Therapeutics, Inc.CompletedGlabellar Frown LinesUnited States, Canada
Clinical Trials on Botulinum toxin, Type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted