A Phase 3 interventional study of Botulinum Toxins, Type A and Placebos in Glabellar Frown Lines, sponsored by Revance Therapeutics, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Revance Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Biological: Botulinum Toxins, Type A
Biological/Vaccine: Placebos Intramuscular injection
Biological: Placebos
Intramuscular injection
Also known as: DaxibotulinumtoxinA
Intramuscular injection
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
Time frame: Week 4
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Time frame: 0-36 weeks
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Time frame: 0-36 weeks
| Milestone | DaxibotulinumtoxinA 40 Units | Placebo |
|---|---|---|
| Started | 204 | 102 |
| Completed | 191 | 93 |
| Not completed | 13 | 9 |
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
| percentage of responders | DaxibotulinumtoxinA 40 Units | Placebo |
|---|---|---|
| Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 74.0 | 1.0 |
The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
| days | DaxibotulinumtoxinA 40 Units |
|---|---|
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 167 (142 to 168) |
The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
| days | DaxibotulinumtoxinA 40 Units |
|---|---|
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 182 (169 to 196) |
Collected over Adverse events were collected throughout the entire study, up to 36 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DaxibotulinumtoxinA 40 Units | 0/205 (0%) | 2/205 (1%) | 30/205 (14.6%) |
| Placebo | 0/101 (0%) | 1/101 (1%) | 5/101 (5%) |
| Event | DaxibotulinumtoxinA 40 Units | Placebo |
|---|---|---|
| Leiomyosarcoma recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/205 | 1/101 |
| Uterine perforationInjury, poisoning and procedural complications | 1/205 | 0/101 |
| Uterine leiomyosarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/205 | 0/101 |
| Event | DaxibotulinumtoxinA 40 Units | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 18/205 | 2/101 |
| NasopharyngitisInfections and infestations | 12/205 | 3/101 |
Intent to treat population
| Age, Categorical(Participants) | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 189 | 94 | 283 |
| >=65 years | 15 | 8 | 23 |
| Age, Continuous(years) | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| Median | 49.6 (21 to 73) | 50.5 (27 to 75) | 49.9 (21 to 75) |
| Sex: Female, Male(Participants) | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| Female | 183 | 87 | 270 |
| Male | 21 | 15 | 36 |
| Race/Ethnicity, Customized(Participants) | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| Race — Asian | 11 | 5 | 16 |
| Race — Black or African American | 9 | 3 | 12 |
| Race — White | 180 | 92 | 272 |
| Race — More than one race | 1 | 1 | 2 |
| Race — Unknown or not reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| North America | 204 | 102 | 306 |
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Plan to share: No
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Revance Therapeutics, Inc.