Lateral Canthal LinesPhase 2NCT03911102
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
A Phase 2 study testing DaxibotulinumtoxinA for injection in people with Lateral Canthal Lines, run by Revance Therapeutics, Inc. at 4 sites in United States.
Trial summary
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Canthal 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
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Mar 2019to 23 Apr 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 old
- Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
- 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
- History of clinically significant bleeding disorders
- Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
- Planned or anticipated need for surgery or hospitalization through the end of the study
- Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Arlington, VA Site
Arlington, Virginia, 22209
Itasca, IL Site
Itasca, Illinois, 60143
Sacramento, CA Site
Sacramento, California, 95816
Sarasota, FL Site
Sarasota, Florida, 34239
About this study
Official title: A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
- Conditions
- Lateral Canthal Lines
- Being tested
- DaxibotulinumtoxinA for injection
- Keywords
- Lateral canthal wrinkle, Crow's feet lines, LCL
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: DAXI 12 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 2: DAXI 24 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 3: DAXI 36 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) Receives: Biological: DaxibotulinumtoxinA for injection |
| Cohort 4: DAXI 48 U | Experimental | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) 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 LCL Severity at Maximum Smile
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
Measured: Week 4 After LCL Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start11 Mar 2019
- Primary completion23 Apr 2020
- Study completion23 Apr 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 Lateral Canthal 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
- 63 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
- NCT03911102
- Sponsor's protocol ID
- 1820205
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2019
- Last updated
- 27 Jun 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 27 Jun 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, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT03911102
- Acronym / sponsor ID
- 1820205
- Conditions
- Lateral Canthal Lines
- Keywords
- Lateral canthal wrinkle, Crow's feet lines, LCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: DAXI 12 U | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 2: DAXI 24 U | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 3: DAXI 36 U | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 4: DAXI 48 U | Experimental | Biological: DaxibotulinumtoxinA for injectionDAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 old
- Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
- 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.
Key exclusion criteria (6 listed)
- Active skin disease, infections, or inflammation at the injection sites
- History of clinically significant bleeding disorders
- Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
- Planned or anticipated need for surgery or hospitalization through the end of the study
- Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
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: DAXI 12 U, Cohort 2: DAXI 24 U, Cohort 3: DAXI 36 U, Cohort 4: DAXI 48 U |
Primary outcome
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile
Time frame: Week 4 After LCL Treatment
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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 1 country: 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 Lateral Canthal Lines, run by Revance Therapeutics, Inc. at 4 sites 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 6 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 Jun 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. 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 27 Jun 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 LCL Severity at Maximum Smile (time frame: Week 4 After LCL 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 27 Jun 2023.