Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)Phase 2NCT04259086
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
A Phase 2 study testing DaxibotulinumtoxinA for injection in people with Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines), run by Revance Therapeutics, Inc. at 8 sites in 2 countries.
Trial summary
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Facial Lines (Glabellar Lines, Forehead Lines, & 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
- 48 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 6 Dec 2019to 2 Nov 2020
- Phase
- Phase 2
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-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 years of age or older
- Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
- Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
- Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
- Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study
Who cannot join
- Active skin disease, infections, or inflammation at the injection sites
- 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 a 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Site 2
Chestnut Hill, Massachusetts, 02467
Site 5
Coral Gables, Florida, 33146
Site 1
Manhattan Beach, California, 90266
Site 6
New York, New York, 10028
Site 3
San Diego, California, 92121
Site 7
Santa Monica, California, 90404
Canada2 sites
Site 8
Toronto, Ontario, M5R3N8
Site 4
Vancouver, British Columbia, V5Z 4E1
About this study
Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection (DAXI for Injection) for the Combined Treatment of Upper Facial Lines (Glabellar Lines, Dynamic Forehead Lines and Lateral Canthal Lines)
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)
- Being tested
- DaxibotulinumtoxinA for injection
- Keywords
- Lateral Canthal Wrinkle, crow's feet lines, LCL, Forehead Lines, Glabellar Lines, Frown Lines, Upper facial lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxibotulinumtoxinA for injectionDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL | Experimental | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) Receives: Drug: 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 GL Severity at Maximum Frown
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
Measured: Week 4
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
Measured: Week 4
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start6 Dec 2019
- Primary completion2 Nov 2020
- Study completion2 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)Studies 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
- 48 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
- NCT04259086
- Sponsor's protocol ID
- 1920201
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2019
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dover JS, Humphrey SD, Lorenc ZP, Shamban A, Gross TM, Rubio RG, Vitarella D. Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study. Dermatol Surg. 2023 Jan 1;49(1):60-65. doi: 10.1097/DSS.0000000000003637. Epub 2022 Nov 28.
PubMed 36533798