Glabellar Frown LinesPhase 3NCT03004248
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
A Phase 3 study testing Botulinum Toxins, Type A in people with Glabellar Frown Lines, run by Revance Therapeutics, Inc. at 61 sites in 2 countries.
Trial summary
This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum Toxins, Type A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,691 participants
- Where
- 61 sitesin 2 countries
- Study dates
- 9 Dec 2016to 17 Oct 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent including authorization to release health information
- Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
- Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
- Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Who cannot join
- Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Active skin disease, infections or inflammation at the injection sites
- Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
- History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
- Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States56 sites
Study site
Austin, Texas, 78746
Study site
Baltimore, Maryland, 21208
Study site
Beverly Hills, California, 90210
Study site
Birmingham, Alabama, 35205
Study site
Birmingham, Michigan, 48009
Study site
Boca Raton, Florida, 33431
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Bradenton, Florida, 34209
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Chapel Hill, North Carolina, 27517
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Charlotte, North Carolina, 28207
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Chestnut Hill, Massachusetts, 27517
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Chicago, Illinois, 60611
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College Station, Texas, 77845
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Coral Gables, Florida, 33146
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Drexel Hill, Pennsylvania, 19026
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Encinitas, California, 92024
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Fremont, California, 94538
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Fridley, Minnesota, 55432
Study site
Glenn Dale, Maryland, 20769
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Greenwood Village, Colorado, 80111
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High Point, North Carolina, 27262
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Houston, Texas, 77056
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Hunt Valley, Maryland, 21030
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Katy, Texas, 77494
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Lincolnshire, Illinois, 60069
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Los Angeles, California, 90069
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Manhattan Beach, California, 90266
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Mequon, Wisconsin, 53092
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Miami, Florida, 33137
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Montclair, New Jersey, 07042
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Naperville, Illinois, 60563
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Nashville, Tennessee, 37203
Study site
Nashville, Tennessee, 37215
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New Orleans, Louisiana, 70124
Study site
New Orleans, Louisiana, 70130
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New York, New York, 10011
Study site
New York, New York, 10016
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New York, New York, 10022
Study site
New York, New York, 10028
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New York, New York, 10029
Study site
New York, New York, 10075
Study site
Newport Beach, California, 92663
Study site
Omaha, Nebraska, 68144
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Portland, Oregon, 97223
Study site
Rockville, Maryland, 20850
Study site
Roseville, California, 95661
Study site
Sacramento, California, 95819
Study site
San Diego, California, 92121
Study site
San Diego, California, 92122
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San Francisco, California, 94117
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Santa Monica, California, 90404
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St Louis, Missouri, 63122
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Washington D.C., District of Columbia, 20007
Study site
Washington D.C., District of Columbia, 20037
Study site
West Islip, New York, 11795
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West Palm Beach, Florida, 33401
Study site
White Plains, New York, 10604
Canada5 sites
Study site
Burlington, Ontario, L7N 3N2
Study site
Montreal, Quebec, H3Z 1BZ
Study site
Toronto, Ontario, M5R3N8
Study site
Vancouver, British Columbia, V5Z 4E1
Study site
Woodbridge, Ontario, L4L 8E2
About this study
Official title: An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)
This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum Toxins, Type A
- Keywords
- glabellar lines, frown lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxins, Type ABiological
Also called DaxibotulinumtoxinA
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| DaxibotulinumtoxinA 40 units | Experimental | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Receives: Biological: Botulinum Toxins, Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAE)
Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
Measured: 0-36 weeks
Secondary outcomes (3)
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e. none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
Measured: Week 4
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.
Measured: 0-36 weeks per cycles 1 and 2
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.
Measured: 0-36 weeks per Cycle 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start9 Dec 2016
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
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 (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,691 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
- NCT03004248
- Sponsor's protocol ID
- 1620303
- Status last verified
- Jun 2022
- First submitted
- 22 Dec 2016
- Last updated
- 13 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.
PubMed 32773447Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531.
PubMed 32773446
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)
- ClinicalTrials.gov ID
- NCT03004248
- Acronym / sponsor ID
- 1620303
- Conditions
- Glabellar Frown Lines
- Keywords
- glabellar lines, frown lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,691 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 13 Jul 2022
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 long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaxibotulinumtoxinA 40 units | Experimental | Biological: Botulinum Toxins, Type ABiological/Vaccine: Botulinum Toxins, Type A Intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent including authorization to release health information
- Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
- Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
- Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Key exclusion criteria (5 listed)
- Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Active skin disease, infections or inflammation at the injection sites
- Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
- History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
- Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
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 Toxins, Type AAlso: DaxibotulinumtoxinAIntramuscular Injection | Biological | DaxibotulinumtoxinA 40 units |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAE)
Time frame: 0-36 weeks
Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
3 secondary outcomes
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Time frame: Week 4
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
Time frame: 0-36 weeks per cycles 1 and 2
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
Time frame: 0-36 weeks per Cycle 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32773447Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.
- Derived from this study: PubMed 32773446Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531.
- Individual participant dataSharing planned: No
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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.
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxins, Type A in people with Glabellar Frown Lines, run by Revance Therapeutics, Inc. at 61 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 4 inclusion and 5 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 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 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 13 Jul 2022). 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?
Incidence of Treatment Emergent Adverse Events (TEAE) (time frame: 0-36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004248, which also lists 2 linked publications.
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 13 Jul 2022.