Expired Study
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Boca Raton, Florida 33431


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

EV-001


NCT ID:

NCT02334423


Secondary ID:


Study Acronym:


Brief Title:

A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Evolus, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

330


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rui Avelar, MD
Study Director
Evolus, Inc.

Study Dates

Start Date:January 2015
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:December 2015
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 14, 2019
First Received Date:January 6, 2015
First Results Date:January 4, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
Time Frame:Day 90
Safety Issues:False
Description: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 bo
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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 b
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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 b
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 s

Study Interventions

Intervention Type:Biological
Name:Botulinum toxin, Type A
Description:Botulinum toxin, Type A
Arm Name:Botulinum toxin, Type A
Other Name:DWP-450
Intervention Type:Other
Name:0.9% sterile, unpreserved saline
Description:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:0.9 % sterile, unpreserved saline
Study Arm Type:Experimental
Arm Name:Botulinum toxin, Type A
Description:Botulinum toxin, Type A

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Evolus, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:PPD

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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