Frown LinesPhase 2NCT03786770
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
A Phase 2 study testing DaxibotulinumtoxinA for injection in people with Frown Lines, run by Revance Therapeutics, Inc. at 4 sites in 2 countries.
Trial summary
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Frown Lines
- What is being tested?
- DaxibotulinumtoxinA for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Jan 2019to 9 Mar 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
- Be outpatient, male or female subjects, in good general health, 18-65 years of age
- Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS)
- Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)
- Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
- Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the Patient Frown Wrinkle Severity (PFWS)
- Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study
- Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Who cannot join
- Active skin disease, infections, or inflammation at the injection sites
- Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
- History of clinically significant bleeding disorders
- Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study
- Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
- History of upper or lower lid blepharoplasty or brow lift
- Prior periorbital or forehead surgery
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Boca Raton site
Boca Raton, Florida, 33431
Coral Gables site
Coral Gables, Florida, 33146
Canada2 sites
Toronto, Ontario site
Toronto, Ontario, M5R3N8
Woodbridge, Ontario site
Woodbridge, Ontario, L4L8E2
About this study
Official title: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for the Treatment of Dynamic Forehead Lines (Frontalis) Following Glabellar Line Injections
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.
- Conditions
- Frown Lines
- Being tested
- DaxibotulinumtoxinA for injection
- Keywords
- Forehead Lines, Glabellar Lines, Frown Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxibotulinumtoxinA for injectionBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose A | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 2: Dose B | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 3: Dose C | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 4: Dose D | Experimental | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) Receives: Biological: DaxibotulinumtoxinA for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
Measured: Week 4 After FHL Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start24 Jan 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
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 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786770
- Sponsor's protocol ID
- 1820202
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2018
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for the Treatment of Dynamic Forehead Lines (Frontalis) Following Glabellar Line Injections
- ClinicalTrials.gov ID
- NCT03786770
- Acronym / sponsor ID
- 1820202
- Conditions
- Frown Lines
- Keywords
- Forehead Lines, Glabellar Lines, Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose A | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 2: Dose B | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 3: Dose C | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 4: Dose D | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
- Be outpatient, male or female subjects, in good general health, 18-65 years of age
- Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS)
- Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)
- Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
Key exclusion criteria (7 listed)
- Active skin disease, infections, or inflammation at the injection sites
- Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
- History of clinically significant bleeding disorders
- Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study
- Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
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 |
|---|---|---|
| DaxibotulinumtoxinA for injectionIntramuscular injection | Biological | Cohort 1: Dose A, Cohort 2: Dose B, Cohort 3: Dose C, Cohort 4: Dose D |
Primary outcome
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
Time frame: Week 4 After FHL Treatment
Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DaxibotulinumtoxinA for injection in people with Frown Lines, run by Revance Therapeutics, Inc. at 4 sites in 2 countries.
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 8 inclusion and 7 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 16 Feb 2023). 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 None or Mild in FHL Severity at Maximum Eyebrow Elevation (time frame: Week 4 After FHL Treatment). 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 16 Feb 2023.