Glabellar Frown LinesPhase 3EV-002NCT02334436
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002
A Phase 3 study testing Botulinum toxin, Type A and 0.9% sterile, unpreserved saline in people with Glabellar Frown Lines, run by Evolus, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum toxin, Type A and 0.9% sterile, unpreserved saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Clinical Testing Center of Beverly Hills
Beverly Hills, California, 90210
About this study
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
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
Read the 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.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum toxin, Type A, 0.9% sterile, unpreserved saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin, Type ABiological
Also called DWP-450 (Botulinum purified neurotoxin, Type A) Injection, DWP-450
Botulinum toxin, Type A
0.9% sterile, unpreserved salineOther
Placebo Comparator Arm
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin, Type A | Experimental | Botulinum toxin, Type A Receives: Biological: Botulinum toxin, Type A |
| Placebo | Placebo comparator | 0.9% sterile, unpreserved saline Receives: Other: 0.9% sterile, unpreserved saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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.
Measured: Day 30
Secondary outcomes (3)
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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.
Measured: 90 Days
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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.
Measured: Day 120
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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.
Measured: Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Rui Avelar, MD, Study director, Evolus, iInc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334436
- Sponsor's protocol ID
- EV-002
- Acronym
- EV-002
- Status last verified
- Mar 2019
- First submitted
- 6 Jan 2015
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02334436
- Acronym / sponsor ID
- EV-002 / EV-002
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Evolus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin, Type A | Experimental | Biological: Botulinum toxin, Type ABotulinum toxin, Type A |
| Placebo | Placebo comparator | Other: 0.9% sterile, unpreserved saline0.9% sterile, unpreserved saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin, Type AAlso: DWP-450 (Botulinum purified neurotoxin, Type A) Injection, DWP-450Botulinum toxin, Type A | Biological | Botulinum toxin, Type A |
| 0.9% sterile, unpreserved salinePlacebo Comparator Arm | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Avelar, MD study director
Evolus, iInc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin, Type A and 0.9% sterile, unpreserved saline in people with Glabellar Frown Lines, run by Evolus, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.