Glabellar Frown LinesPhase 2EV-006NCT02428608
Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006
A Phase 2 study testing DWP-450 (Botulinum purified neurotoxin, Type A) 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 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. 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?
- DWP-450 (Botulinum purified neurotoxin, Type A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2016
- Phase
- Phase 2
- 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 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
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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Advanced Skin Research Center at Skin Specialists, PC
Omaha, Nebraska, 68144
About this study
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
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.
Read the 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.
- Conditions
- Glabellar Frown Lines
- Being tested
- DWP-450 (Botulinum purified neurotoxin, Type A)
- Keywords
- Glabellar Lines, Botulinum toxin, Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP-450 (Botulinum purified neurotoxin, Type A)Biological
Also called DWP-450
Botulinum toxin, Type A
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin, Tyoe A | Experimental | DWP-450 (Botulinum toxin, Type A) Receives: Biological: DWP-450 (Botulinum purified neurotoxin, Type A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionNov 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 570 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428608
- Sponsor's protocol ID
- Evolus - CLIN006
- Acronym
- EV-006
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2015
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Developing a plan
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02428608
- Acronym / sponsor ID
- EV-006 / Evolus - CLIN006
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabellar Lines, Botulinum toxin, Type A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Evolus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Posted 5 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin, Tyoe A | Experimental | Biological: DWP-450 (Botulinum purified neurotoxin, Type A)DWP-450 (Botulinum toxin, Type A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| DWP-450 (Botulinum purified neurotoxin, Type A)Also: DWP-450Botulinum toxin, Type A | Biological | Botulinum toxin, Tyoe A |
Primary outcome
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
Time frame: 365 days
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Developing a plan
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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, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWP-450 (Botulinum purified neurotoxin, Type A) 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 4 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 24 Apr 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 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?
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year (time frame: 365 days). 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 24 Apr 2019.